Methods, apparatus, and systems for ophthalmic testing and measurement

ABSTRACT

Methods, apparatus, and systems for performing an ophthalmic diagnostic test are disclosed. In one aspect, a head-wearable device for administering an ophthalmic test to a subject can comprise a head-wearable frame for mounting the device onto the subject&#39;s head, and a light seal configured for coupling to the frame so as to isolate at least one eye of the subject from ambient light when the device is worn by the subject.

RELATED APPLICATIONS

The Application claims the benefit of and priority to U.S. ProvisionalApplication No. 62/734,274, filed on Sep. 21, 2018, U.S. ProvisionalApplication No. 62/734,280, filed on filed on Sep. 21, 2018, and U.S.Provisional Application No. 62/853,713, filed on May 28, 2019. Theentire teachings of these earlier applications are incorporated hereinby reference.

FIELD

The present disclosure generally relates to ophthalmic diagnosticmethods and systems, and more particularly to methods, apparatus, andsystems for performing ophthalmic diagnostic testing and measurements.

BACKGROUND

The macula of the human eye is generally understood as having beendesigned for providing detailed vision. The macula can have a relativelylarge area, measuring often about six millimeters in diameter andcovering about 21.5 degrees of visual angle centered on the fovea. Themacula is understood as being responsible for producing central, highresolution, color vision, and, as such, any damage to the macula (e.g.,damage caused by macular degeneration) can result in impairment or lossof such vision.

The human macula can be divided into a number of sub-regions, namely theumbo, foveola, foveal avascular zone, fovea, parafovea, and perifoveaareas. The fovea comprises a small area dominated by cone-shaped cells,and is surrounded by parafovea, which is sub-region of the macula,generally dominated by rod-shaped cells. As detailed in U.S. Pat. No.9,504,379, the entire teachings of which is incorporated by referenceherein, the rod-shaped cells appear to be responsible for vision in dimlight, while the cone-shaped cells are understood to be responsive tobright light and colors. In young adults, the number of rod-shaped cellsoutnumbers the cone-shaped cells by approximately 9:1. This proportionof the rod-shaped cells to cone-shaped cells changes as a person ages.

The health and function of the rod-shaped and the cone-shapedphotoreceptors are maintained by the pigmented layer of retina orretinal pigment epithelium (RPE), the Bruch's membrane (BM), which islocated between the retinal pigment epithelium and the fenestratedchoroidal capillaries of the eye, and the capillary lamina of choroid orchoriocapillaris, which is located adjacent to Bruch's membrane in thechoroid (collectively referred to as the RPE/Bruch's membrane complex).

The RPE is a dedicated layer of nurse cells behind the neural retina,which is understood to be responsible for sustaining photoreceptorhealth in a number of ways, including, but not limited to, maintainingproper ionic balance, transporting and filtering nutrients, providingretinoid intermediates to replenish photopigment bleached by lightexposure and absorbing stray photons. Bruch's membrane, which comprisesa vessel wall of about 2-6 μm, further separates the RPE and thechoriocapillaris. The choriocapillaris provides blood flow to the outerretina, particularly the rods.

An impairment of the RPE/Bruch's membrane complex can result in reducedtransportation of nutrient and oxygen to the photoreceptors and reducedclearance of by-products of bleaching, such as opsin, thereby impairingthe health and function of the photoreceptors. This can be especiallytrue with the rod-shaped cell photoreceptors, which are responsible forscotopic, or dark-adapted vision.

SUMMARY

In one aspect, a head-wearable device for measurement of dark adaptationin at least one eye of a subject is disclosed. The head-wearable systemcan comprise a head-wearable frame, at least one test light sourcemounted in the frame, and an optical system mounted in the frame fordirecting the light from the at least one test light source onto atleast one eye of the subject (e.g., onto the retina of the at least oneeye). The at least one test light source can be configured to generate ableaching light and a stimulus light.

In another aspect, a device for administering an ophthalmic diagnostictest to a subject is disclosed. The device can comprise an ophthalmicdiagnostic system for administering an ophthalmic diagnostic test to atleast one eye of the subject and an automatic subject-instruction systemfor communicating with the subject so as to guide the subject throughthe diagnostic test.

In yet another aspect, an ophthalmic testing system is disclosed. Theophthalmic testing system can comprise an optical system configured todirect at least one ray of light onto an eye of a test subject, aprocessor coupled to the optical system, a memory coupled to theprocessor, and one or more programs stored in the memory and configuredto be executed by the one or more processors. The one or more programscan include instructions for configuring the ophthalmic testing systemfor use in conducting an ophthalmic test on the test subject.

In another aspect, an electronic device for ophthalmic testing isdisclosed. The electronic device can comprise one or more processors, amemory connected to the one or more processors, and one or more programsstored in the memory and configured to be executed by the one or moreprocessors. The one or more programs can include instructions for:providing, using the processor, a test subject with one or more commandsfor guiding the test subject through an ophthalmic test administeredusing an ophthalmic measurement and testing device, the one or morecommands being provided to the test subject in natural language,receiving, at the processor, one or more requests for assistance, theone or more requests being issued by the test subject in naturallanguage, extracting one or more active elements of an active ontologyassociated with the one or more requests, determining at least one taskfor which to provide the test subject with assistance based on theactive ontology, and providing the test subject with assistance byperforming the at least one task.

In yet another aspect, an ophthalmic testing system is disclosed. Theophthalmic testing system can comprise an optical system configured todirect at least one ray of light onto an eye of a test subject; at leastone motion sensor coupled to the optical system; one or more processorscoupled to the motion sensor; a memory coupled to the processor; and oneor more programs stored in the memory and configured to be executed bythe one or more processors; the one or more programs includinginstructions for receiving information regarding movements of theophthalmic testing system from the motion sensor indicating suddenacceleration or deceleration of the ophthalmic testing system.

In another aspect, a system comprising a status monitor and a processoris disclosed. The status monitor can comprise one or more sensors, eachconfigured to monitor status of at least one feature of a medicaltesting system, where the at least one feature can be a featureindicative of an operational aspect of the medical testing system. Theprocessor can be coupled to the status monitor and configured to receiveinformation regarding the at least one feature of the medical testingsystem from the one or more sensors and in an event the informationindicates a change in an expected value of the feature, generate anotification to an entity interested in monitoring the operation of themedical testing system.

In yet another aspect, a system for measuring dark adaptation isdisclosed. The system can comprise a plurality of head-wearable devices,each configured for measuring dark adaptation of at least one eye of asubject and a command center configured to communicate with theplurality of head-wearable devices.

In another aspect, a light seal for use in a head-wearable deviceconfigured for measuring dark adaptation of a subject is disclosed. Thelight seal can comprise a conformable body having at least one openingadapted to be substantially aligned with at least one eye of the subjectwhen the light seal is worn by the subject and an attachment elementcoupled to the conformable body for mounting the light seal to asubject's head. The body can be configured for coupling to a frame ofthe head-wearable device such that a combination of the head-wearabledevice and the light seal isolate the at least one eye of the subjectfrom ambient light when worn.

In yet another aspect, a head-wearable device for administering anophthalmic test to a subject is disclosed. The a head-wearable devicecan comprise a head-wearable frame for mounting the device onto thesubject's head, and a light seal configured for coupling to the frame soas to isolate at least one eye of the subject from ambient light whenthe device is worn by the subject.

In another aspect, a head-wearable device for administering anophthalmic diagnostic test to a subject is disclosed. The head-wearabledevice can comprise a head-wearable frame, a diagnostic system coupledto the frame for performing an ophthalmic diagnostic test, he diagnosticsystem comprising at least one test light source generating test lightfor illuminating at least one eye of the subject, and an automaticalignment mechanism coupled to the frame for automatically aligning theat least one light source relative to the pupil of the subject's eye.

In other examples, the aspects above, or any system, method, apparatusdescribed herein can include one or more of the following features.

The one or more programs can comprise instructions for establishing,using the processor, verbal communication with the test subject forguiding the test subject through the ophthalmic test. The verbalcommunication with the subject can be conducted using natural language.Further, the verbal communication with the test subject can be performedby using one or more pre-recorded messages configured for delivery tothe test subject before, during, and after the ophthalmic test.

The ophthalmic testing system can comprise at least one audio speakerfor conducting the verbal communication with the test subject. Theverbal communication can comprise one or more commands conveyed to thetest subject. The one or more commands can comprise commands providedfor guiding the test subject through the ophthalmic test. Further, theverbal communication can comprise at least one of 1) greeting the testsubject, 2) commands providing address or location of an exam room inwhich the ophthalmic test is administered, 3) information regarding theophthalmic test, and 4) expected wait time until the ophthalmic test isadministered.

The ophthalmic testing system can further comprise an interfaceconfigured to receive a response from the test subject. The response canbe provided by the test subject in connection with one or more stimuliprovided by the ophthalmic testing system to the test subject. Further,the processor can be configured to monitor the response received fromthe test subject via the interface. The processor can further beconfigured to at least one of 1) store the response received from thetest subject for future analysis and 2) compare the response receivedfrom the test subject to a baseline response stored in the memory.Moreover, the processor can be configured to adjust at least onefunction of the ophthalmic testing system based on the response receivedfrom the test subject. The at least one function can include at leastone of: 1) position of a component of the optical system, 2) orientationof a component of the optical system, and 3) length of the ophthalmictest.

Further, the interface can be configured for use by the test subject toprovide the response. The response received from the test subject caninclude at least one of a verbal response or a response provided viainteraction with the interface. The processor can also be configured toprovide the test subject with additional commands based on the responsereceived from the test subject. The additional commands can comprise atleast one of 1) natural language commands, 2) pre-recorded audiocommands, 3) computer-generated audio commands, and 4) visual commands.

The ophthalmic testing system can further comprise a user interfaceconfigured for use by the test subject to provide the response. Theresponse received from the test subject can be a verbal response.

The ophthalmic testing system can further comprise a biometric scannerconfigured to obtain at least one biometric feature of the test subject.The at least one biometric feature can comprise at least one of a facialfeature of the test subject, information obtained from an iris of theeye of the test subject, information obtained from a retina of the eyeof the test subject, and a fingerprint obtained from the test subject.

In some embodiments, the processor can be configured to store a profilefor the test subject, the profile including identifying informationincluding at least one of: name of the test subject, address of the testsubject, any identifiers associated with the test subject, and healthinsurance information for the test subject. The profile can be obtainedfrom an electronic health record system. Further, the electronic healthrecord system is maintained on a cloud-based server.

The ophthalmic testing system can further comprise a biometric sensorthat measures at least one biometric feature of the test subject. Theprocessor can also be configured to identify the test subject using theat least one biometric feature. Further, the processor can be configuredto receive and store, in the memory of the ophthalmic testing system, atleast one medical history of the test subject, medical insuranceinformation associated with the test subject, available pretestingdiagnostics information associated with the test subject.

In some embodiments, one or more commands for guiding the test subjectcan include at least one of 1) address or location of an exam room inwhich the ophthalmic test is administered, 2) information regarding theophthalmic test, and 3) expected wait time until the ophthalmic test isadministered. The one or more commands can comprise pre-recordedmessages configured for delivery to the test subject before, during, andafter the ophthalmic test.

Additionally or alternatively, the processor can be configured tocommunicate with a location-determining device associated with the testsubject to monitor a location of the test subject for guiding the testsubject to the exam room. Further, the processor can configured tocommunicate with a plurality of speakers for guiding the test subject tothe exam room, wherein the processor can be configured to activate eachof the speakers based on proximity of the location of the test subjectto that speaker. In some embodiments, the processor can be configured tocommunicate with a program executing on a mobile device associated withthe test subject for presenting a map to the test subject for visuallyguiding the test subject to the exam room. The location-determiningdevice can comprise an RFID tag. Further, the location-determiningdevice can comprise a smartphone.

Further, the at least one or more requests for assistance can include atleast one of 1) questions regarding the test and 2) complaints regardingthe test. The instructions can be configured to provide the test subjectwith assistance by performing at least one of: 1) guiding the testsubject in conducting the ophthalmic testing, 2) notifying apractitioner monitoring the ophthalmic testing, 3) adjusting at leastone function of the ophthalmic measurement and testing device, and 4)configuring at least one element of the ophthalmic measurement andtesting device.

Furthermore, the processor can be configured to store a profile for thetest subject, the profile including identifying information including atleast one of: name of the test subject, address of the test subject, anyidentifiers associated with the test subject, and health insuranceinformation for the test subject.

The electronic can further comprise a biometric scanner configured toobtain at least one biometric feature of the test subject. The at leastone biometric feature can comprise at least one of a facial feature ofthe test subject, information obtained from an iris of the eye of thetest subject, information obtained from a retina of the eye of the testsubject, and a fingerprint obtained from the test subject. Further, theprocessor can be configured to store the at least one biometric featureof the test subject in a biometric database in the memory of theelectronic device.

Further, the one or more programs further can include instructions forreceiving the at least one biometric feature from the biometric scanner,determining whether the biometric database includes a matching biometricfeature to the at least one biometric feature, and in an event thematching biometric feature exists, identify the test subject using thematching biometrics information. The one or more programs can furtherinclude instructions for monitoring performance of the test subjectduring the ophthalmic test in response to the stimuli. Alternatively oradditionally, the one or more program can include instructions forproviding the test subject with verbal commands in response to theperformance of the test subject during the ophthalmic test in responseto the stimuli. Further, the one or more program can includeinstructions for adjusting at least one function of ophthalmicmeasurement and testing device the in response to the performance of thetest subject during the ophthalmic test in response to the stimuli.Moreover, the one or more programs can include instructions forrecording results of the ophthalmic test in response to the stimuli asperformed by the test subject. In certain embodiments, the one or moreprograms can further include instructions for recording results of theophthalmic test in a cloud-based or clinic-based electronic healthrecord or subject folder for the test subject.

In some embodiments, the electronic device can comprise at least one ofa audio speaker for providing the one or more commands for guiding thetest subject in natural language and an audio microphone for receivingthe one or more requests for assistance in natural language from thetest subject. The electronic device can further comprise an interfaceconfigured to a receive, from the test subject, a response to one ormore stimuli provided by the ophthalmic measurement and testing device.

In some embodiments, the programs comprise instructions to be executedby the one or more processors for generating a notification in responseto receiving information regarding sudden acceleration or decelerationof the ophthalmic testing system. The programs can further compriseinstructions to be executed by the one or more processors fortransmitting the notification to a designated device. The designateddevice can comprises any of a mobile device, a desktop computer, earbud,smart glasses with pop-up message window. Furthermore, the programs cancomprise instructions configured to be executed by the one or moreprocessors for generating an alarm signal in response to the suddenacceleration or deceleration of the ophthalmic testing system.Additionally or alternatively, the one or more programs can compriseinstructions for storing number of detected sudden acceleration ordeceleration events in the database. Further, the one or more programscan comprise instructions for quantifying severity of the suddenacceleration or deceleration events detected by the motion sensor.Furthermore, the one or more programs can comprise instructions forquantifying the sudden acceleration or deceleration events as mild,medium, and severe.

The ophthalmic testing system can also comprise a communication modulefor communicating with the designated device. The designed device can beconfigured to send one or more instructions to the ophthalmic testingsystem in response to the notification. Further, the processor of theophthalmic testing device can be configured to execute the instructionsreceived by the designated device. Moreover, the one or moreinstructions sent by the designated device can comprise instructions fordisabling the ophthalmic testing device, providing a visual warningsignal to the test subject, and/or providing an audible warning signalto the test subject.

Further, the ophthalmic testing system can comprise one or more speakersfor generating the alarm signal. The alarm signal can comprise a messagein natural language.

In some embodiments, the sensor comprise an inertial measurement sensor(IMS). The ophthalmic testing system can also comprise a database incommunication with the processor.

The at least one feature can comprise at least one of temperature,acceleration, deceleration and orientation of the medical testingsystem.

Further, the one or more sensors can comprise at least one of a motionsensor, a temperature sensor, a humidity sensor, microphone, globalpositioning system (GPS), gyroscope, light sensor, proximity sensor,system clock, and an accelerometer. Further, the one or more sensors cancomprise at least one sensor configured to detect whether a cover of themedical testing system is opened. In some embodiments, the at least onesensor can comprises an infrared sensor. The one or more sensors canalso comprise an accelerometer. The processor can be configured toanalyze the information received from the accelerometer to determine asudden acceleration or deceleration of the medical testing system.Additionally or alternatively, the sensors can be configured to beintegrated into a single printed circuit board or dispersed throughoutthe medical testing system on multiple printed circuit boards.

Moreover, the entity can be at least one of a remote entity responsiblefor maintenance of the medical testing system and an insurance providerproviding insurance on the medical testing system. The processor canalso be configured to send an alarm signal to the entity. The processorcan further be configured to receive a message from the entity inresponse to the notification. Moreover, the processor can be configuredto convey the message to the user of the system. The processor can alsobe configured with pre-established rules corresponding to differentmagnitudes of sensor readings. The rules can also govern the nature of anotification to the user or entity.

The system can further comprise a communications network coupled to theprocessor. The processor can be configured to transmit the notificationto the remote entity via the communications network.

The processor can further be configured to issue the alarm signal to auser of the medical testing system. The system can also be integrallyincluded onboard of the medical testing device. Further, the system canbe implemented on a chip included in the medical testing device andcomprise a database configured to store a log of the notificationsgenerated by the processor. The database can be stored either in acloud-based server or onboard the device.

In some embodiments, the system can automate responses to insurance andwarranty damage claims made by a user. The system can also systemmonitor real-time operating conditions such as current to ensure thetesting protocol.

In some embodiments, the system can maintain its own battery backup toensure monitoring of the medical testing system even when the medicaltesting system is turned off

The head-wearable device can further comprise a movable platform onwhich the at least one test light source and the optical system aremounted. The movable platform can be movable along at least twoorthogonal directions for aligning the at least one test light sourcerelative to the pupil of the subject's eye. Alternatively oradditionally, the platform can be fixedly positioned relative to theframe.

The head-wearable device can further comprise at least one fixationlight source associated with the at least one test light source fordirecting the subject's attention to the at least one test light source.

Further, the at least one fixation light source and the at least onetest light source can be positioned relative to one another such that alight beam emitted by the at least one test light source and a lightbeam emitted by the fixation light source form an angle in a range ofabout 1 to about 18 degrees at the subject's pupil. Moreover, the atleast one fixation light source can be movable so as to allow bringingthe fixation light into focus when viewed by the subject. The at leastone fixation light source can also be movable along a directionsubstantially along a propagation direction of light emitted by thefixation light source.

The head-wearable device can further comprise a mechanism mounted ontothe frame and coupled to the at least one fixation light source formoving the fixation light source relative to the subject's eye. Themechanism can be configured to move the fixation light source along adirection substantially along a propagation direction of light emittedby the fixation light source. Further, the mechanism for moving the atleast one fixation light source can comprise a knob adapted to berotated by a user, and a cam system mechanically coupled to the knob fortransforming rotational motion of the knob to linear translation of thefixation light source.

Moreover, the optical system can comprise one or more lenses configuredto collimate light emitted by the at least one test light source. Also,the optical system can comprise at least one aspheric lens adapted tocorrect for spherical aberration.

In some embodiments, the test light source and the optical system can behoused in a sealed package. The head-wearable device can also comprisean automatic alignment mechanism coupled to the frame for automaticallyaligning the at least one test light source with the pupil of thesubject's eye. The automatic alignment mechanism can comprise aninfrared light source mounted onto the frame for illuminating the atleast one eye and an infrared detector mounted in the frame fordetecting at least a portion of the infrared light returning from the atleast one eye in response to the infrared illumination. Further, theinfrared detector can comprise an infrared camera. Further, in someembodiments, the infrared camera can be configured to generate an imageof the subject's pupil based on the infrared light returning from the atleast one eye of the subject.

The head-wearable device can further comprise a feedback system mountedonto the frame and in communication with the infrared detector and themovable platform. The feedback system can detect the pupil of the atleast one eye based on one or more signals generated by the infrareddetector and cause movement of the platform to align the light emittedby the at least one test light source with the subject's pupil. Further,the feedback system can align the light emitted by the at least one testlight source based on a shape of the subject's pupil in the imagegenerated by the infrared camera.

The optical system can also comprise a dichroic mirror adapted toreflect the light from the at least one test light source onto thesubject's pupil and further to allow passage of the infrared lightreturning from the subject's eye onto the infrared detector.

Further, the head-wearable device can comprise a light seal configuredfor coupling to the frame to isolate the at least one eye from ambientlight when the device is worn by the subject. The light seal can beconfigured to isolate both eyes of the subject from ambient light.Additionally or alternatively, the light seal can be configured toisolate the eyes of the subject from ambient light independent of oneanother. Further, the light seal can be substantially conformable to atleast a portion of the subject's head.

The light seal can comprise a polymeric material. The polymeric materialcan comprise any of silicone, polyurethane, neoprene, polyolefin,nitrile rubber, ethylene vinyl acetate (EVA), polyvinyl alcohol (PVA),polylactic acid (PLA). Additionally or alternatively, the light seal cancomprise a plurality of fibers. For example, the fibers can comprisecellulose fibers. Additionally or alternatively, the light seal cancomprise a foamed material. The foamed material can comprise any ofalginate foam and starch-based foam. In some embodiments, an RFID tagcan be coupled to the light seal.

The light seal comprises a conformable body having at least one openingadapted to be substantially aligned with the at least one eye of thesubject when the light seal is worn by the subject, the body beingconfigured for coupling to a frame of the head-wearable device such thatthe combination of the head-wearable device and the light seal isolatethe at least one eye of the subject from ambient light when worn. Insome embodiments, an attachment element can be coupled to theconformable body for removably and replaceably attaching the light sealto at least a portion of the subject's head. For example, the attachmentelement can comprise a strap. Further, the attachment element cancomprise at least one arm coupled to the conformable body. Additionallyor alternatively, a hygienic liner can be configured for coupling with asurface of the conformable body of the light seal so as to be in contactwith the subject's skin. In some embodiments, the hygienic liner can bea single-use, disposable item. In some embodiments, the hygienic linercan comprise a double-sided tape.

In some embodiments, the head-wearable device can further comprise oneor more light sensors coupled to the frame for detecting light leakagethrough the light seal. The one or more light sensors can be positionedso as to detect light leakage in vicinity of at least one eye of thesubject. Further, the one or more light sensors can comprise at leasttwo light sensors each of which is positioned to detect light leakage invicinity of one eye of the subject.

The head-wearable device can further comprise an alert module mountedonto the frame and in communication with the one or more light sensorsfor generating an alert when the detected light leakage is greater thana threshold. The alert module can be configured to identify the eye invicinity of which the light leakage is detected. Further, the alertmodule is configured to generate an audio alert in response to thedetection of the light leakage.

In some embodiments, the alert module can be configured to inform anindividual administering the dark adaptation test of completion of thetest. Further, the alert module can be configured to generate an alarmsignal in response to malfunction of the at least one test light source.Additionally or alternatively, alert module can be configured togenerate an alarm signal in response to performance of the subjectduring the dark adaptation measurement.

The head-wearable device can further comprise at least one sensorcoupled to the frame for generating a signal in response to detection ofan undesired motion of the subject. The sensor can be in communicationwith the alert module to send the signal thereto and configured togenerate an alarm in response to the sensor signal.

The head-wearable device can further comprise a ratchet mounted on theframe and coupled to the light seal for adjusting the light seal aroundthe at least one eye of the subject. The head-wearable device can alsocomprise a first strap for mechanically coupling the ratchet to thelight seal. The ratchet can be used to adjust any of a length andtension in the strap for adjusting the light seal around the at leastone eye of the subject. The head-wearable device can further comprise asecond strap coupled to the frame for adjusting attachment of the frameto the subject's head. The head-wearable device can also comprise aquick release button coupled to any of the first and the second strap toallow facile release thereof

The stimulus light can have a spectrum effective in stimulating the rodphotoreceptors of the at least one eye. For example, the stimulus lightcan have one or more wavelengths in a range of about 400 nm to about 570nm. Further, the light source that generates the stimulus light can beconfigured to generate light stimuli having a duration in a range ofabout 100 milliseconds to about 400 milliseconds. In some embodiments,the stimulus light can have an intensity in a range of about 4×10-5cd/m2 to about 5 cd/m2.

Further, the bleaching light can have one or more wavelengths in a rangeof about 490 nm to about 510 nm or a range of about 600 nm to about 700nm. Additionally or alternatively, the bleaching light can have awavelength spectrum consisting essentially of wavelengths in a range ofabout 490 nm to about 510 nm. In some embodiments, the bleaching lightcan have a wavelength spectrum consisting essentially of wavelengths ina range of about 600 nm to about 700 nm.

In some embodiments, the test light source can be configured to generatebleaching light pulses having a duration in a range of about 0.5milliseconds to about 400 milliseconds. Additionally or alternatively,the bleaching light can have an intensity in a range of about 1.5 logScotopic Trolands/sec to about 8 log Scotopic Trolands/sec and/or anintensity in a range of about 3 log Scotopic Trolands/sec to about 7 logScotopic Trolands/sec.

Further, the at least one test light source can comprise two lightsources, one of which can be configured to generate the bleaching lightand the other is configured to generate the stimulus light.

In some embodiments, the frame can comprise a body having a chamber forhousing the at least one light source and the optical system. Thechamber can comprise a first compartment for housing the at least onetest light source and the optical system. The first compartment can besealed against external environment. Further, the frame body can beconfigured such that at least a portion thereof is positioned in frontof the at least one eye when the head-wearable device is worn by asubject. The portion of the frame body can be opaque so as to obstructpassage of ambient light to the at least one eye. Further, the opaqueportion can be hingedly coupled to another portion of the frame suchthat the opaque portion can be lifted so as to allow passage of ambientlight to the at least one eye of the subject. In some embodiments, theat least a portion of the frame body that is configured for positioningsubstantially in front of the at least one eye of the subject when thedevice is worn by a subject can be formed of a material having anadjustable opacity in response to a signal. Further, at least a portionof the frame body can comprise a liquid crystal and a light polarizerfor providing a transition from translucent to opaque upon applicationof a voltage thereto.

The frame can also comprise an opening configured to be substantially infront of the at least one eye of the subject when the device is worn bythe subject. In some embodiments, the frame can comprise a flip sealcoupled to the opening to obstruct or to allow passage of ambient lightto the at least one eye. A first strap can be coupled to the frame forsecuring the frame to the subject's head. The strap can comprise atleast one of an elastic material or a non-elastic material.

The head-wearable device can further comprise a slidable screen coupledto the frame, wherein the screen can be slidably positionedsubstantially in front of the at least one eye of the subject so as toobstruct passage of light thereto.

The head-wearable device can also comprise a controller that is mountedon the frame. The controller can be configured to control operation ofthe at least one test light source.

In some embodiments, the head-wearable can comprise a subject-responseinterface configured to allow the subject to provide feedback inresponse to exposure to light emitted by the at least one test light. Ananalyzer can also be mounted on the frame and be in communication withthe subject-response interface and configured to analyze the feedback.The analyzer can be configured to analyze the feedback of the subjectfor assessing dark adaptation of the at least one eye of the subject.The analyzer can comprise a processor and at least one memory module incommunication with the processor. the least one memory module storesinstructions for analyzing the response of the subject to the stimuluslight.

The head-wearable device can further comprise an adaptive automatedsubject-instruction system mounted onto the frame for instructing asubject during performance of the dark adaptation measurement. Thehead-wearable device can further comprise a system for monitoring atleast one attribute of the at least one eye.

Further, the monitoring system can be in communication with theautomated subject-instruction system to cause the subject-instructionsystem to provide one or more instructions to the subject in response tomonitoring of the attribute.

The head-wearable can also comprise an audio module mounted to the framefor providing audio communication with the subject. The audio module canbe in communication with the subject-instruction system for receivingsubject instruction signals from the system and converting the signalsto audible signals for the subject. The audio module can convert thesubject instruction signals to one or more verbal commands for deliveryto the subject. The verbal commands can be generated based onperformance of the subject during the dark adaptation measurement. Theaudio module can also convert one or more alarm signals generated by thealarm module into audible signals for the subject.

The head-wearable device can also comprise a controller coupled to theframe for controlling the at least one test light source. Further, thehead-wearable device can comprise a display coupled to the frame, thedisplay being controlled by the controller. The controller can effectpresentation of any of information, selection options and/or commandoptions on the display. The information can comprise status of the darkadaption test and/or subject data. The selection options can allow auser to select right eye, left eye, or both eyes of the subject foradministration of the dark adaptation test thereto. Further, theselection options can allow selecting a protocol for performing the darkadaptation measurement. The selection options can allow selecting acommunication protocol for establishing communication between the headwearable device and another device. The display can also presentsoftware-controlled buttons for allowing a user to input data into thehead-wearable device.

The head-wearable device can further comprise a communication modulecoupled to the frame. The communication module can be configured tocommunicate with a command center. For example, the communication modulecan communicate with the command center via a wireless protocol. Thecommunication module can also be configured to communicate with aheadset. Specifically, the communication module can communicate with theheadset via a wired connection. Additionally or alternatively, thecommunication module can communicate with the headset via a wirelessprotocol. The communication module can also be configured to communicatewith an electronic health record (EHR) system. Further, thecommunication module is configured to communicate with a databaseproviding shared access to the head-wearable device and the EHR system.In some embodiments, the communication module can employ encryption forcommunication. Also, the communication module can be configured totransmit a notice signal to the command center indicative of performanceof the dark adaptation measurement. The communication module can furthertransmit the notice signal to a mobile device of a medical professional.

In some embodiments, the command center can be configured to communicateconcurrently with the plurality of head-wearable devices. Further, atleast one of the head-wearable devices can comprise asubject-instruction system in communication with the command center. Thecommand center can be configured to allow a user to provide instructionsto a subject using the at least one head-wearable device via thesubject- instruction system.

The light seal attachment element can comprise a strap coupled to theconformable body and/or at least one arm coupled to the conformablebody. The light seal can also comprise a hygienic liner configured forcoupling with a surface of the conformable body of the light seal so asto be in contact with the subject's skin. The hygienic liner can be asingle-use, disposable item and/or comprise a double-sided tape. In someembodiments, the light seal can comprise a polymeric material. Thepolymeric material can comprise any of silicone, polyurethane, neoprene,polyolefin, nitrile rubber, ethylene vinyl acetate (EVA), polyvinylalcohol (PAV), and polylactic acid (PLA). In some embodiments, the lightseal can comprise a plurality of fibers. The plurality of fibers cancomprise cellulose fibers. Further, the light seal can comprise a foamedmaterial. The foamed material can comprise any of close-cell oropen-cell polymeric foam, alginate foam, and starch-based foam.

In some embodiments, the light seal can comprise an RFID tag coupled tothe light seal. The RFID tag can be used to authenticate the light sealand single use thereof

Further, a testing device according to examples disclosed herein cancomprise a measurement system for monitoring performance of the subjectduring the ophthalmic diagnostic test. The measurement system cancomprise a subject-response device configured for use by the subject torespond to one or more stimuli provided by the ophthalmic diagnosticsystem.

The subject-instruction system can comprise pre-recorded messages fordelivery to the subject before, during and/or subsequent toadministration of the ophthalmic diagnostic test. Further, thesubject-instruction system can be configured to allow communicationbetween the subject and a medical professional.

Further, the subject-instruction system can be in communication with thesubject-response device so as to receive data regarding the subject'sresponse to the stimuli. The subject-instruction system can beconfigured to provide verbal commands to the subject in response to thedata regarding the subject's response to the stimuli.

A testing device according to embodiments disclosed herein can providean ophthalmic test including at least one of: Visual field for glaucoma,Frequency Doubling Technology Perimetry (FDT) for glaucoma and diabeticretinopathy, Electroretinogram (ERG), Visual Evoked Potential (VEP),contrast Sensitivity, Color Vision, Visual Acuity, High luminance/Highcontrast Visual Acuity, Low luminance/High contrast Visual Acuity, Lowluminance/Low contrast Visual Acuity, High luminance/Low contrast VisualAcuity, Opotype, venier acuity, Reading Speed (High & low luminance),Glare Testing (cataract), Motion Perception, Metamorphopsia (late AMD),Shape and Texture Distrimination for late-stage AMD, Mesopic andScotopic Visual Fields, Photostress, Microforimetry (Fundus-guidedForimetry), Tonometer, Sterio-opsis, Coneohistorhesis, Fundus RetinalImaging, Retinal Densitometry, Optical Coherence Tomography (OCT),Fluoroscein Angiography, OCT Angiography (OCTA), Multi-spectral Imaging,Scanning Laser Ophthalmoscope, Anterior Segment OCT, Deep-field OCT,Retinal Metabolic Imaging, Ocular Blood Flow Imaging, Adaptive Optics,Autofluorescence, Non-mydriatic Fundus Camera, Optic Nerve Imaging,Ultrasound, Anterior Segment Photography, Slit Lamp, Pachymeter, andInterior Segment.

Further, the testing can comprise an audio module mounted to the framefor providing audio communication with the subject. The audio module canbe in communication with the subject-instruction system for receivingsubject instruction signals therefrom and converting the signals toaudible signals for delivery to the subject. Further, the audio modulecan convert the subject instruction signals to one or more verbalcommands for delivery to the subject. The verbal commands can begenerated based on performance of the subject during the ophthalmictest.

In some embodiments, the testing device can be a head-wearable device.The head-wearable device can comprise a frame for mounting the deviceonto the subject's head. The automatic subject-instruction system is atleast partially incorporated in the frame. Further, the automaticsubject-instruction system can comprise: a processor, at least onerandom memory module (RAM), a permanent memory module, and acommunication bus for providing communication between the processor, theRAM and the permanent memory module. The automatic subject-instructionsystem can further comprise a plurality of pre-recorded audio filescontaining subject instructions stored in the permanent memory module.

The device can further comprise a controller coupled to the frame forcontrolling one of more components of the ophthalmic diagnostic system.A display can be coupled to the frame and configured to be controlled bythe controller. The controller can effect presentation of any ofinformation, selection options and/or command options on the display.The information can comprise subject data and the selection options canallow a user to select right eye, left eye, or both eyes foradministration of the ophthalmic diagnostic test. Further, the selectionoptions can allow selecting a protocol for administering the ophthalmicdiagnostic test. The selection options can also allow selecting acommunication protocol for establishing communication between the deviceand another device. The display can also present software-controlledbuttons for allowing a user to input data into the device.

Further, the device can comprise a communication module. Thecommunication module can be configured to communicate with a commandcenter. Specifically, the communication module is configured tocommunicate with the command center via a wireless protocol.

As noted, the light seal can comprise a conformable body having at leastone opening adapted to be substantially aligned with the at least oneeye of the subject when the light seal is worn by the subject. Theconformable body can be configured for coupling to the frame of thehead-wearable device such that a combination of the frame and the lightseal isolates the at least one eye of the subject from ambient light.The device can further comprise an attachment element coupled to theconformable body for removably and replaceably coupling the light sealto a least a portion of the subject's head. The attachment element cancomprise a strap and/or at least one arm coupled to the conformablebody.

The light seal can comprise a hygienic liner configured for couplingwith a surface of the conformable body so as to be in at least partialcontact with the subject's skin. The hygienic liner is a single-use,disposable item and/or comprise a double-sided tape or an elasticmaterial.

The head-wearable device can further comprise one or more light sensorscoupled to the frame for detecting light leakage through the light seal.The one or more light sensors can be positioned so as to detect lightleakage in vicinity of at least one eye of the subject. Further, the oneor more light sensors comprise at least two light sensors each of whichis positioned so as to detect light leakage in vicinity of one eye ofthe subject.

The head-wearable device can further comprise a mechanism for adjustingthe light seal around the subject's head. The mechanism can comprises aratchet mechanism coupled to the attachment element. The attachmentelement comprises a strap and the ratchet mechanism allows adjusting anyof length of the strap and tension therein. A second strap can also becoupled to the frame for mounting the frame onto the subject's head. Thehead-wearable device can also comprise a quick release button coupled toany of the straps to allow facile release thereof

The head-wearable device can further comprise an alert module incommunication with the one or more light sensors for generating an alertsignal in response to detection of light leakage above a predefinedthreshold by the one or more light sensors. The alert signal cancomprise an audio signal.

The head-wearable frame can also comprises a frame body having a chamberfor housing one or more components for performing the ophthalmicdiagnostic test. The frame body is configured such that at least aportion thereof is positioned in front of the at least one eye when thehead-wearable device is worn by the subject. Further, at least a portionof the frame body can be opaque so as to obstruct passage of ambientlight to the at least one eye. The opaque portion can be hingedlycoupled to another portion of the frame such that the opaque portion canbe lifted so as to allow passage of ambient light to the at least oneeye of the subject. Further, the at least a portion of the frame bodycan be formed of a material having an adjustable opacity in response toa stimulus. Additionally or alternatively, the at least a portion of theframe body can comprise a liquid crystal and a light polarizer forproviding a transition from translucent to opaque upon application of avoltage thereto.

The head-wearable device can further comprise a slidable screen coupledto the frame, wherein the screen can be slidably positionedsubstantially in front of the at least one eye of the subject so as toobstruct passage of light thereto. The frame can comprise an openingconfigured to be substantially in front of the at least one eye of thesubject when the device is worn by the subject, and further comprising aflip seal coupled to the opening to obstruct or to allow passage ofambient light to the at least one eye.

In some embodiments, the head-wearable device can comprise an opticalsystem coupled to the frame for directing the test light into the atleast one eye of the subject. The optical system can comprises a mirrorfor reflecting the test light emitted by the test light source into thesubject's eye. The optical system can further comprise a lens forcollimating and diffusing the light emitted by the light source. Thehead-wearable device can also comprise a movable platform on which thetest light source is mounted. The movable platform can be movable alongat least two orthogonal dimensions and/or along three orthogonaldimensions.

In some embodiments, the alignment mechanism can comprise an infraredlight source mounted onto the frame for illuminating the at least oneeye and an infrared detector mounted onto the frame for detecting atleast a portion of the infrared light returning from the at least oneeye in response to the infrared illumination. The head-wearable devicecan further comprise a feedback system mounted onto the frame and incommunication with the infrared detector and the movable platform. Thefeedback system can be configured to detect the pupil of the at leastone eye based on one or more signals generated by the infrared detectorand cause movement of the platform to align the test light emitted bythe at least one test light source with the subject's pupil. Theinfrared detector can comprise an infrared camera that is configured togenerate an image of the subject's pupil based on the infrared lightreturning from the at least one eye of the subject. Further, thefeedback system can be configured to align the test light emitted by theat least one test light source based on a shape of the subject's pupilin the image generated by the infrared camera. Moreover, the opticalsystem can comprise a dichroic mirror adapted to reflect the test lightfrom the at least one test light source onto the subject's pupil andfurther to allow passage of the infrared light returning from thesubject's eye onto the infrared detector.

Other aspects and advantages of the invention can become apparent fromthe following drawings and description, all of which illustrate thevarious aspects of the invention, by way of example only.

BRIEF DESCRIPTION OF THE DRAWINGS

A detailed description of various embodiments is provided herein belowwith reference, by way of example, to the following drawings. It will beunderstood that the drawings are exemplary only and that all referenceto the drawings is made for the purpose of illustration only, and is notintended to limit the scope of the embodiments described herein below inany way. For convenience, reference numerals may also be repeated (withor without an offset) throughout the figures to indicate analogouscomponents or features.

FIG. 1A schematically illustrates an example of a head-wearableimplementation of an ophthalmic testing, measurement, detection, and/ordiagnosis system according to some embodiments disclosed herein.

FIG. 1B schematically illustrates a portion of a head-wearableimplementation of an ophthalmic testing, measurement, detection, and/ordiagnosis system according to some embodiments disclosed herein.

FIG. 1C schematically illustrates a portion of a head-wearableimplementation of an ophthalmic testing, measurement, detection, and/ordiagnosis system according to some embodiments disclosed herein.

FIG. 1D depicts an illustration of a portion of a head-wearable deviceaccording to some embodiments disclosed herein.

FIG. 1E schematically illustrates a portion of a head-wearable devicehaving a light seal.

FIG. 1F schematically illustrates a light seal according to someembodiments disclosed herein.

FIG. 1FA schematically illustrates another light seal according to someembodiments disclosed herein.

FIG. 1FB schematically illustrates examples of light seals according tosome embodiments disclosed herein.

FIG. 1G is a schematic illustration of a bottom view of a head-wearableimplementation of an ophthalmic testing, measurement, detection, and/ordiagnosis system according to some embodiments disclosed herein.

FIG. 1H illustrates an example of procedures that can be used forensuring single usage of a cover for a light seal according to someembodiments disclosed herein.

FIG. 1I is a high-level block diagram of an ophthalmic testing systemaccording to some embodiments disclosed herein.

FIG. 2A is a high-level block diagram of an optical system according tosome embodiments disclosed herein.

FIG. 2B schematically illustrates examples of light sources according tosome embodiments disclosed herein.

FIG. 2C schematically illustrates an example of a light source accordingto some embodiments disclosed herein.

FIG. 2D schematically illustrates another example of a light sourceaccording to some embodiments disclosed herein.

FIG. 2E schematically illustrates yet another example of a light sourceaccording to some embodiments disclosed herein.

FIG. 2F schematically illustrates an example of an eye trackingmechanism according to some embodiments disclosed herein.

FIG. 3 is a high-level block diagram of digital electronic circuitry andhardware that can be used with, incorporated in, or fully or partiallyincluded in an ophthalmic testing and measurement system according tosome embodiments disclosed herein.

FIG. 4A is a high-level block diagram of an ophthalmic testing systemaccording to some embodiments disclosed herein.

FIG. 4A-1 is another high-level block diagram of an ophthalmic testingsystem according to some embodiments disclosed herein.

FIG. 4B is yet another high-level block diagram of an ophthalmic testingsystem according to some embodiments disclosed herein.

FIG. 4C is an example of menu items on a display of an ophthalmictesting system according to some embodiments disclosed herein.

FIG. 4D another example of menu items on a display of an ophthalmictesting system according to some embodiments disclosed herein.

FIG. 4E illustrates a high-level diagram of an interface that can beused to obtain biometric information that identifies a test subjectaccording to some embodiments disclosed herein.

FIG. 5A is a high-level block diagram of an ophthalmic testing systemaccording to some embodiments disclosed herein.

FIG. 5B is another high-level block diagram of an ophthalmic testingsystem according to some embodiments disclosed herein.

FIG. 5C schematically illustrates an example of a head-wearableimplementation of an ophthalmic testing, measurement, detection, and/ordiagnosis system according to some embodiments disclosed herein.

FIG. 6 is a block diagram of an embodiment of an ophthalmic testingsystem and measurement system.

FIG. 7 is a schematic illustration of a head-wearable device accordingto embodiments disclosed herein.

FIG. 8 is a block diagram of an embodiment of an ophthalmic testingsystem and measurement system.

FIG. 9A is a schematic illustration of a head-wearable device accordingto some embodiments disclosed herein.

FIG. 9B is another view of a schematic illustration of a head-wearabledevice according to some embodiments disclosed herein.

FIG. 9C is another is a schematic illustration of a head-wearable deviceaccording to some embodiments disclosed herein.

FIG. 9D is another view of a schematic illustration of a head-wearabledevice according to some embodiments disclosed herein.

FIG. 9E is another schematic illustration of a headset according to someembodiments disclosed herein.

FIG. 9F is another schematic illustration of a headset according to someembodiments disclosed herein.

FIG. 9G is a schematic illustration of a light seal according to someembodiments disclosed herein.

FIG. 10A is a high-level block diagram of a light seal according to someembodiments disclosed herein.

FIG. 10B is another high-level block diagram of a light seal accordingto some embodiments disclosed herein.

FIG. 11 depicts an illustrative example of an optical chamber accordingto some embodiments disclosed herein.

FIG. 12 is a schematic illustration of an image plane that can bepresented to a test subject according to some embodiments disclosedherein.

FIG. 13 is another schematic illustration of an image plane that can bepresented to a test subject according to some embodiments disclosedherein.

FIG. 14A illustrates a high-level cross-sectional view of some of theoptics that can be used in a head-wearable implementation according tosome embodiments disclosed herein.

FIG. 14B illustrates another high-level cross-sectional view of some ofthe optics that can be used in a head-wearable implementation accordingto some embodiments disclosed herein.

FIG. 15 is a high-level block diagram of an interface system accordingto some embodiments disclosed herein.

FIG. 16 is a high-level flow diagram of the procedures that can be usedby the subject-instruction system according to some embodimentsdisclosed herein.

DETAILED DESCRIPTION

The present disclosure relates to methods, systems, and correspondingapparatus for performing ophthalmic testing, measurement, detection,and/or diagnostic. The methods, systems, and apparatus disclosed hereincan be used to perform various ophthalmic testing, measurement,detection, and/or diagnosis. For example, methods, systems, andapparatus disclosed herein can be used in performing testing andmeasurement directed at the detection and diagnosis of variousophthalmic conditions and diseases, such as age-related maculardegeneration (“AMD,” which is also known as age-related maculopathy“ARM”), vitamin A deficiency, Sorsby's Fundus Dystrophy, late autosomaldominant retinal degeneration, retinal impairment related to diabetes,diabetic retinopathy, retinitis pigmentosa.

FIG. 1A schematically illustrates an example of a head-wearableimplementation 100 of an ophthalmic testing, measurement, detection,and/or diagnosis system (hereinafter “ophthalmic testing system”)according to some embodiments disclosed herein. Although shown anddescribed in the context of a head-wearable device, the ophthalmictesting systems described herein can be generally implemented in anysuitable form or configuration. For example, at least a portion of theophthalmic testing system described herein can be implemented in ahead-wearable configuration 100 (hereinafter “head-wearable device”)and/or in a tabletop implementation.

As noted, the head-wearable device 100 can be used to perform variousophthalmic tests and measurements on at least one eye of a test subject.For example, in some embodiments, the head-wearable device 100 can beused to perform ophthalmic tests directed to measuring the testsubject's dark adaptation, in at least one eye of the test subject.Additionally or alternatively, the head-wearable device 100 can be usedfor concurrent or serial measurement and testing of both the subject'svisual field and the subject's dark adaptation.

The term “dark adaptation,” as used herein, refers to the adjustment ofthe eye to low light intensities or the recovery of light sensitivity bythe retina in the dark after exposure to a bright light. Since theimpairment of the rod photoreceptors can lead to impairment in darkadaptation, dark adaptation can be viewed as a bioassay of the health ofthe RPE, the Bruch's membrane, and the choriocapillaris. Therefore, animpaired dark adaptation can be used as a clinical marker of diseasestates that impair one or more of the rods, RPE, the Bruch's membrane,and the choriocapillaris. Such disease states include, but are notlimited to age-related macular degeneration (AMD, which is also known asage-related maculopathy ARM), vitamin A deficiency, Sorsby's FundusDystrophy, late autosomal dominant retinal degeneration, retinalimpairment related to diabetes, diabetic retinopathy, retinitispigmentosa. Individuals with AMD can often have impaired dark adaptationas a result of the pathophysiology associated with AMD. In fact,deficits in dark adaptation appear to generally occur before clinical orstructural manifestations of the disease state become evident.Therefore, measurements of dark adaptation can be useful in determiningpresence or an onset of this disease.

The term “visual field test” as used herein, refer to tests and eyeexaminations directed to detecting dysfunctions in the central andperipheral vision, which may be caused by medical conditions such asglaucoma, pituitary diseases, strokes, brain tumors, or otherneurological issues.

Referring back to FIG. 1A, the head-wearable device 100 can comprise aheadset 102 configured for placement adjacent to at least one eye of atest subject and a head-mount 103 configured to secure the headset 102against at least a portion of a test subject's head. As detailed below,the headset 102 can be configured to host various components of one ormore ophthalmic testing systems that can be used to perform at least oneoptical and/or ophthalmic test and/or measurement described herein.

The headset 102 can be configured such that it can be removably andreplaceably coupled to the head-mount 103. The head-mount 103 can beconfigured for placement over the subject's head 102 such that, oncecoupled with the headset 102 and placed over the subject's head, atleast one portion of the headset 102 is securely positioned in proximityof (e.g., in front of) of the subject's face and/or eyes.

Generally, the head-mount 103 can be implemented in any suitable manner.For example, as shown in FIG. 1A, in some embodiments, the head-mount103 can comprise a rear portion 103R, a top portion 103T, and one ormore side portions 103S, one or more side attachment mechanisms (e.g.,straps) 104, a top extension 105, and one or more side connectors 106.

The one or more side connectors 106 can be configured such that theycouple the head-mount 103 to the headset 102. For example, as shown inFIGS. 1B-1C, the side connector 106 can comprise a head 108 having aninternal receptacle 109 that is configured to mate with a mating feature111 on the headset 102. The mating feature 111 can be disposed at anysuitable position on the headset 102. For example, as illustrated inFIG. 1A, the mating feature 111 can be configured such that it extendsout of a mating base 110 disposed on a side 102S of the headset 102.

The head 108 of the side connector 106 can comprise a spring loadedmechanism 112 that surrounds the receptacle 109. The spring loadedmechanism 112 can be coupled to a push button 107 (FIG. 1A), which canbe used to engage and/or release the spring loaded mechanism 112. Inoperation, the head mount 103 can be coupled with the headset 102 viaengagement of the mating feature 111 of the headset 102 with the springloaded mechanism 112 in the receptacle 109 of the connector 106. Thehead mount 103 can be uncoupled from the headset 102 by activating thepush button 107, thereby releasing the spring loaded mechanism 112 anddisengaging the receptacle 109 from the mating feature 111.

The head-mount 103 can be adjustable to accommodate various subject headsizes/hair styles. For example, as shown in FIG. 1A, the head-mount 103can comprise a ratchet 113 that connects to the one or more side straps104 and is configured to adjust the length of the one or more straps104. In some embodiments, the ratchet 113 can be configured as a dialthat can be used to extend and/or reduce the length of the strap (e.g.,extend the strap 104 by rotating the ratchet 113 in a counter clock-wisedirection and reduce the length of the strap by rotating the ratchet ina clock-wise direction). This configuration allows the head-mount to beadjusted to the subject's head to ensure that at least a portion of theheadset 102 is securely positioned against at least a portion of thesubject's face and/or eye.

Additionally or alternatively, the head-mount 103 can be adjustedagainst a subject's head using an adjustable connector 105 that isconfigured to further ensure secure placement of the headset 102 againstat least a portion of the subject's face and/or eye. As shown in FIG.1A, the adjustable connector 105 can be configured such that it extendsout of the top portion 103T of the head-mount 103 and is coupled to abracket 114 on the headset 102. In some embodiments, the adjustableconnector 105 connector can be configured to thread through and looparound the bracket 114 disposed on the top surface 102T of the headset102. Generally, any suitable mechanism available in the art can be usedto thread and secure the adjustable connector 105. For example, as shownin FIG. 1A, the adjustable connector 105 can comprise a tab 115 that canbe used to facilitate threading the adjustable connector 105 through thebracket 114. Once threaded through the bracket 114, the length of theadjustable connector 105 can be adjusted to secure the headset 102 andthe head-mount 103 against the subject's head (e.g., by pulling and/orreleasing of the connector 105). Further, once looped over the bracket114, the adjustable connector 105 can be secured using any suitabletechnique known in the art. For example, in one embodiment, theadjustable connector 105 can be secured against itself using means suchas a hock-and-loop connector or Velcro®.

Further, as shown in FIGS. 1B-1C, the head-mount 103 can be rotatablycoupled to the headset 102. Specifically, the one or more sideconnectors 106 that couple the head-mount 103 to the headset 102 can beconfigured such that they rotatably connect to the mating base 110 ofthe headset 102. For example, in some embodiments, the mating feature111 can be coupled with the receptacle 109 such that once coupled withthe receptacle 109, the head-mount 103 is rotatably connected to theheadset and can rotate about the mating feature 111. The head-mount 103can be configured to rotate about the headset 102 at any suitable angle.For example, the head-mount 103 can be configured to rotate about theheadset 102 at approximately about 5°, 10°, 15°, 20°, 25°, 30°, 35°,40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, and/or 90°.

Moreover, to accommodate hygienic use with multiple test subjects, thehead-mount 103 can include a hygienic layer 116. The hygienic layer 116can be configured such that it covers at least a portion of an interiorsurface of the head-mount 103, where the head-mount 103 is expected tocome in contact with the subject's head and/or skin. The hygienic layer116 can be removably and/or replaceably coupled to the at least oneportion of the interior surface of the head-mount. For example, thehygienic layer 116 can be configured such that it can be removably andreplaceably coupled to the interior surface using a Velcro® connector.The hygienic layer 116 can comprise any suitable material available inthe art. For example, in some embodiments, the hygienic layer 116 cancomprise a medical-grade silicone that can be cleaned (e.g., using amedical grade cleaner) before/after use.

Referring back to FIG. 1A, the headset 102 can comprise a front face117. The front face 117 can comprise a display 117 (e.g., an interactivedisplay). The headset 102 can further comprise one or more dials 118intended for use in adjusting a viewing distance of an image planeprovided by the headset, as well as an input/output port 119. Additionaldetails regarding the components of the headset 102, the display 117,and the one or more dials 118 are provided below.

The input/output port 119, as detailed below, can couple the headset 102to one or more external tools (not shown) via a wired connection. Asshown in FIG. 1A, the head-mount 103 can further comprise a holder 120that is configured to receive at least a portion of the wire 121connected to the input/output port 119. By receiving the at least oneportion of the wire 121, the holder 120 can function to secure the wireaway from the subject's body during an ophthalmic test/screening.

FIG. 1D depicts an illustration of a portion of a head-wearable deviceaccording to embodiments disclosed herein. As shown in FIG. 1D, theheadset 102 can comprise an internal surface 102f that is configured tobe at least partially positioned against the face and/or head of thetest subject. The internal surface 102f can comprise one or more opticalinterfaces 122R, 122L, each configured to optically couple at least oneeye of a test subject with the head-wearable device 100 (e.g., eachconfigured to receive at least one eye of the test subject). Eachoptical interface 122R, 122L can be configured such that it cansubstantially align with at least one eye of the test subject. Althoughshown as having two optical interfaces 122R, 122L, each configured tocouple/interact with one eye of the test subject, the headset 102 caninclude any suitable number of optical interfaces. Further, each opticalinterface 122R, 122L can be configured to receive one eye and/or botheyes of the test subject.

The optical interfaces 122R, 122L can comprise any suitable material.For example, the interfaces 122R, 122L can each comprise an opticallytransparent window 123R, 123L through which the subject's eye(s) caninteract with the optical components included in the headset 102.

Referring now to FIGS. 1E-1F, the headset 102 can comprise one or morelight seals 124R, 124L configured to isolate the optical interface 122R,122L and at least one eye (e.g., a test eye) of the subject from ambientlight. Such isolation of the subject's eye(s) from the ambient light canbe important in measurements of dark adaptation and also in performingvarious other ophthalmic tests and measurements, such as detection ofvitamin A deficiency, Sorsby's Fundus Dystrophy, late autosomal dominantretinal degeneration, retinal impairment related to diabetes, diabeticretinopathy, drug induced retinal toxicity, glaucoma, ocularhypertension, retinal hypoxia, retinitis pigmentosa, and fundusalbipunctatus.

The light seals 124R, 124L can comprise any suitable shape and materialavailable in the art. For example, in some embodiments, the light seal124R, 124L can comprise a cup-shaped configuration (for example, asshown in FIG. 1F) that is coupled to the interface 122R, 122L andconfigured to receive/couple/interact with the eye of the test subjectand/or seal the eye from ambient light.

Although shown as having two separate seals for each eye of the testsubject, the light seal 124R, 124L can be configured such that it canisolate one or both eyes of the subject from ambient light.Specifically, the light seal 124R, 124L can be configured such that itcan independently isolate each eye or both eyes of the subject fromambient light (e.g., can provide same and/or a different, separate, orindependent light seal for each eye).

Generally, the light seal 124R, 124L can be configured according to anysuitable technique and/or using any suitable materials available in theart informed by the present teachings. For example, the light seal 124R,124L can be configured such that it is substantially conformable to atleast a portion of the subject's head, face, and/or the area surroundinga subject's eye(s). Specifically, as shown in FIG. 1F, the light seal124 can comprise a first opening 124i that is configured to surround aninterface 122R, 122L on the headset 102 and a second opening 124o thatis configured to substantially aligned with at least one eye of thesubject when the headset 102 is placed against the subject's eye(s). Thesecond opening 124o can comprise a conformable body that is configuredto conform to the subject's skin and face (e.g., as it is pressedagainst the subjects face,) to seal ambient light from entering theeye(s) of the subject.

In some embodiments, the light seal 124 can comprise one or more sensors124s configured to monitor proper and/or effective usage of the lightseal 124. The one or more sensors 124 s can generally comprise anysuitable sensor. For example, the one or more sensors 124 s can compriseone or more light sensors that are configured to measure and/or detectthe amount of ambient light leaking through the light seal 124 when itis coupled to the subject's eye so as to seal the subjects eye fromambient light. The one or more light sensors 124 s can also beconfigured to measure the intensity of such detected light leakage. Theone or more light sensors 124 s can be positioned at any suitableposition on the light seal. For example, as shown in FIG. 1F, in someembodiments, the light sensors 124 s can be positioned in the vicinityof at least one eye of a subject when the head-wearable device 100 andthe light seal 124 are worn by the subject.

Additionally or alternatively, the one or more sensors 124 s cancomprise at least one of: a pressure sensor and a capacitive touchsensor that are disposed in one or more facial contact points. Suchpressure sensor and capacitive touch sensors can be used to ensure thatthe device is placed against the subject's body (e.g., face) correctly,and ensure proper placement of the device and/or the light seal againstthe subject's body, face, or skin.

Referring back to FIG. 1D, the headset 102 can include one or morecoupling features 134 for coupling the headset 102 to the light seal124. Specifically, as shown in FIG. 1D, the internal surface 102f of theheadset 102 can comprise one or more features 134 that are configured toconnect to corresponding mating features 135, 136, 137 on the light seal124 (FIG. 1E-1F). Generally, the light seal 190 can be attached to theframe 102 using any suitable means. For example, the light seal 190 canbe inserted within a receptacle provided in the frame, glued to theframe, or attached to the frame using other suitable means of coupling.

Although shown as being separate from the headset 102, at least oneportion of the light seal 124 can be directly and/or fixedly coupled tothe headset 102 of the head-wearable device 100 and/or be an integralpart of the headset 102.

Further, although described as being used with a disposable andremovable cover, the light seal can comprise any suitable material, forexample a material capable of being cleaned with standard and commonlyknown and available suitable medical cleaners before and/or after usewith each subject. Additionally or alternatively, the entire light sealcan be disposable and/or replaceable before and/or after use with eachsubject. For example, as shown in FIG. 1FA, in some embodiments, thelight seal 124′ can comprise a single-piece light seal having one ormore receptacles 124 r′, each configured to receive at least one eye ofthe test subject. Further, as shown in FIG. 1FB, the light seal can beprovided in one or more sizes 124 sm, 124 md, 1241 g, for example insizes small, medium, and large, to accommodate different face sizes andshapes.

Moreover, the light seal 124 can comprise one or more portions and/orelements, each of which can be reusable and/or disposable. For example,as shown in FIG. 1G, the light seal 124 can comprise a hygienic cover125 configured to cover the portion of the light seal that comes incontact with a test subject's skin. The cover 125 can be configured suchthat it can be removably and replaceably coupled to the light seal 124such that it can be replaced after use with each test subject. The cover125 can be a disposable, removable, and/or replaceable layer and cancomprise any suitable material in the art. For example, the cover 125can comprise cotton. Additionally or alternatively, the hygienic cover125 can comprise a layer of tape (e.g., double-sided tape).

In some embodiments, the cover 125 can comprise a radio frequencyidentification (RFID) tag or a barcode 126 configured to track properuse of the head-wearable device 100 and/or asset tracking. The RFID tag126 can comprise any suitable tag known in the art. The RFID tag 126 canbe incorporated in and coupled to the light seal 125 and/or the lightseal cover 126 in any suitable known manner. For example, as shown inFIG. 1E, the RFID tag 126 can be incorporated in the disposable cover125 to ensure that the disposable cover 125 is an authentic disposable.

Further, the RFID tag 126 can be configured to enforce single usage ofthe disposable cover 125. For example, the head-wearable device 100 andthe RFID tag 126 can be a passive tag having a factory assigned serialnumber that is configured to provide information to an RFID reader 127positioned on the headset 102. In operation, the headset 102 can beconfigured such that the operation of the headset 102 and theperformance of an ophthalmic test via the headset 120 can only beinitialized once the RFID tag 126 is brought in the vicinity of the RFIDreader 127 to activate the RFID reader 127. This can ensure that adisposable cover 125 provided by the original manufacturer is used everytime the head-wearable device 100 is used to conduct an ophthalmic test.Further, in order to ensure single-usage of the cover 125, the system100 can be configured such that optical test results provided by thedevice are only displayed/provided once the RFID tag 126 is scannedagainst the RFID reader 127 for a second time.

FIG. 1H illustrates an example of procedures that can be used forensuring single usage of a cover 125 according to some embodimentsdisclosed herein. As shown in FIG. 1H, an ophthalmic test and/ormeasurement using the head-wearable device 100 can be initiated (box128) by scanning an RFID tag 126 of a disposable cover 125 against anRFID reader 127 of the head-wearable device 100. Once the test isinitialized, the cover 125 (having the RFID tag 126) is coupled with thelight seal 124 (box 129). The head-wearable device 100 can then be usedfor conducting an optical test and/or measurement (box 130). Forexample, the head wearable device can be placed against the head and/orface of the test subject to conduct the ophthalmic test and measurementand/or the eye of the test subject can be brought into contact with anoptical interface of ophthalmic testing system and coupled to the lightseal 124 and the cover 125. Upon receiving a confirmation of thecompletion of the test (explained in more details below, box 131), thecover 125 can be uncoupled from the light seal 125 (box 132). Onceremoved from the light seal 124, the RFID tag 126 on the cover 125 isscanned against the RFID reader 127 (box 133). As explained in furtherdetails below, the scanning of the RFID tag 126 against the RFID reader127 causes the head-wearable device 100 to display the results of theophthalmic test at hand on a display 117 of the head-wearable device100.

FIG. 11 is a high-level block diagram of an ophthalmic testing system150 according to embodiments disclosed herein. As noted, embodimentsdisclosed herein can be implemented in the form of a table-top systemand/or in a head-wearable device (for example, as shown in FIG. 1A).When implemented in a head-wearable device, the ophthalmic testingsystem is implemented in the headset 102 of the head-wearable device.Although described in the context of a head-wearable device, it shouldbe understood that the embodiments disclosed herein can be implementedas a table-top system.

As shown in FIG. 1I and described above, the headset 102 of thehead-wearable system can comprise one or more receptacles 123R, 123L,each configured to receive at least one eye 140R, 140L of a testsubject. As explained with reference to FIG. 1E, each receptacle 123R,123L can be coupled with a corresponding light seal 124R, 124L that isconfigured to obstruct passage of ambient light to the subject's eye(s)140R, 140L.

As described in further details below, the headset 102 can also includea display 107, an optical system 200 that comprises optical componentsfor conducting various ophthalmic tests and measurements with theembodiments disclosed herein, and digital electronic circuitry andhardware 300 that can be used with, incorporated in, or fully orpartially included in an ophthalmic testing and measurement system 150according to the embodiments disclosed herein.

FIG. 2A is a high-level block diagram of an optical system 200 accordingto embodiments disclosed herein. In the example shown in FIG. 2A, theoptical system 200 is shown as having a housing 201 that houses thecomponents of the optical system. However, it should be understood thatthe optical system 200 need not to have a housing and the variouscomponents of the optical system can be disposed within the headset 102or the housing of a tabletop device.

The optical system 200 can generally comprise one or more light sources(collectively shown as light source S) that are configured to emit oneor more beams of light L_(S) at one or more wavelengths. The lightsource S can be any suitable light source known and/or available in theart. For example, the light source can be a laser, a light-emittingdiode (LED), an organic light-emitting diode (OLED), or a liquid crystaldisplay (LCD) light source. Further, the light source can be asingle-mode or a multi-mode light source configured to emit light beamsat one or more wavelengths. For example, the light source can be a broadspectrum light source, having one or more filters or other suitableoptics, which is configured to emit light beams at any desiredwavelength. One skilled in the art should appreciate that the opticalsystem 200 can include any suitable number of light sources.

In some embodiments, the light source S can be configured to generate astimulus light having a spectrum effective in stimulating the rod-shapedphotoreceptors of a subject's eye. By way of example, the stimulus lightcan have one or more wavelengths in a range of about 400 nm to about 570nm. In some embodiments, the stimulus light source can be configured togenerate stimulus light beams having a duration in a range of about 100milliseconds to about 400 milliseconds.

As noted in U.S. Pat. No. 8,795,191, the entirety of which isincorporated herein by reference, a subject's ability to dark adapt canbe characterized by measuring scotopic sensitivity recovery (i.e., rodfunction) after photobleaching using psychophysical testing methodsknown in the art. In such psychophysical tests, typically a test eye ofthe subject is first pre-conditioned to a state of relative scotopicinsensitivity by exposing the eye to a conditioning light (a procedurereferred to as “photobleaching” or “bleaching”). After thispre-conditioning (or bleaching), the subject's scotopic sensitivity (orthe minimum light intensity that can be detected in a dark environment)is measured at one or more successive times. The measurement can be madeby exposing the bleached region of the test eye to a series of stimuluslights of varying intensities. Based on subject feedback as to whichstimulus intensities can be detected, a sensitivity, or threshold, isdetermined for each successive time. The subject is kept in a darkenvironment throughout the test. The absolute levels and/or kinetics ofthe resulting threshold curve indicate the subject's ability to darkadapt. Impairment in the subject's dark adaptation parameters mayindicate the subject is currently suffering from and/or at risk for adisease state that impairs one or more of the rod and/or conephotoreceptors, the RPE, the Bruch's membrane and the choriocapillaris.

Referring back to FIG. 2A, the light source S can be configured to emitthe light beams at one or more predetermined time periods and/or for oneor more predetermined time frames. For example, the light source S canbe configured to emit light beams configured to stimulate a subject'seye every 1 to 5 seconds or every 2 to 3 seconds. The stimulus light canhave an intensity in a range of about 4 cd/m²to about 4.85 cd/m², arange of 4 cd/m² to about 5 cd/m², a range of about 5×10⁻⁵ to about 5cd/m² , a range of about 4.0×10⁻⁵ cd/m² to about 5 cd/m², a range ofabout 4.0×10⁻⁵ cd/m² to about 4 cd/m², or a range of about 4.0×10⁻⁵cd/m² to about 5 cd/m².

Additionally or alternatively, the light source S can be configured togenerate a bleaching light capable of bleaching photopigments and/ordesensitizing a portion of the rhodopsin molecules in a test eye of asubject. For example, the light source S can be configured to emit lightbeams having one or more wavelengths in a range of about 490 nm to about510 nm or in a range of about 600 nm to about 700 nm. Further, the lightsource S can be configured to generate the bleaching light pulses at oneor more predetermined time periods and/or for one or more predeterminedtime frames. For example, the light source S can be configured to emitbleaching light beams having a duration in a range of about 0.5milliseconds to about 200 milliseconds. Further, the light source S cangenerate bleaching light beams having one or more intensities. Forexample, the bleaching light beams can comprise an intensity in a rangeof about 1.5 log Scotopic Trolands/sec to about 8 log ScotopicTrolands/sec and/or an intensity in a range of about 3 log ScotopicTrolands/sec to about 5 log Scotopic Trolands/sec.

The light source(s) S can also be configured to generate fixation lightbeams configured to direct the subject's attention at the bleaching orstimulus light (e.g., the light source generating the bleaching and/orstimulus light). In some embodiments, the optical system 200 can beconfigured to present the subject with a fixation dot 210, where thesubject is asked to fixate his/her gaze at least at some point duringthe ophthalmic test. The fixation light beams can be configured to emitvisible light at a wavelength (e.g., in a range of about 605 nm andabout 655 nm) and at a desired light intensity (e.g., in a range of fromabout 1. mlux to about 100. mlux, from about 1. mlux to about 80.mlux,from about 1.mlux to about 460.mlux, or from about 1.47 mlux to 57.6mlux, depending on pupil size) configured to focus the subject's gaze.Further, although described as a single light source S, the opticalsystem 200 can include two or more light sources S. For example, theoptical system 100 can include a light source configured to emitbleaching light beams and another light source configured to emit thestimulus light beams.

As noted above, the light source(s) S can generally be any suitablelight source available in the art. For example, the light source(s) Scan comprise an LED light source, an OLED light source, and/or an LCDlight source. The LED, OLED, and/or LCD light sources can be used forgenerating at least one of the stimulus and bleaching lights.

For example, as shown in FIG. 2B, at least one LED, OLED, and/or LCDlight source Sf and/or at least one LED, OLED, and/or LCD pixel lightsource Sf can be used to generate the fixation and/or the stimuluslights. Additionally or alternatively, at least one other one LED, OLED,and/or LCD light source SB can be used to deliver the bleaching light.The LED, OLED, and/or LCD light sources, when used as a bleaching lightsource SB can allow for real-time tracking of the subject's eye 240 and,thereby, correct for possible movements of a subject's eye/pupil (due towandering eyes) within predetermined limits. Similarly, when used toprovide fixation and stimulus light, such light sources (e.g., lightsource Sf) can provide for real-time alignment of the light source to asubject's eyes.

Specifically, such sources SB, Sf can allow for adjustment of theintensity of the stimulus light provided to the subject's eyes (e.g.,using cosine correction techniques) to ensure that appropriate stimuluslight levels are directed at the eye, regardless of the angle ofalignment between an LED/OLED/LCD pixel source and the subject's eye.

In some embodiments, the angle of alignment between an LED/OLED/LCDpixel source and the subject's eye can be adjusted mechanically. Forexample, in some implementations, the knob or dial (e.g., dial 118) canbe used to manually adjust a fixation light source S_(f) in thedirection shown by arrow mi. Specifically, the dial 118 can be connectedto the fixation source S_(f) and configured to move the fixation sourcein an axial direction relative to the subject's eye(s). By moving thefixation source S_(f) relative to the subject's eye(s), the dial 118 canbring the fixation source S_(f) in focus and/or compensate for possiblereflective errors (e.g., nearsightedness (myopia), farsightedness(hyperopia), astigmatism or presbyopia) in the subject's eyes. The dial118 can be configured such that it can be adjusted by the test subjectand/or by the technician/clinician delivering the ophthalmic test to thesubject.

Alternatively or additionally, the alignment between the LED/OLED/LCDpixel source and the subject's eye can be achieved automatically. Forexample, in some implementations, a pupil tracking mechanism can beemployed to detect the location and/or size of a subject's pupil. Asdescribed in further details below, a processor (e.g., included in thedigital electronic circuitry and hardware 300) can receive the detectedpupil location and instruct the relevant components of the opticalsystem 200 to bring the LED/OLED/LCD pixel sources in alignment with thesubject's eye. Once achieved, such alignment can reduce the amount ofcosine correction necessary to ensure proper stimulus intensity due to,for example, a subject with a wandering eye.

Further, in some implementation, the fixation light source Sf can beconfigured such that it can be automatically adjusted. For example, asexplained in further details below, the fixation light source Sf can beconfigured such that it is controlled by a processor (e.g., included inthe digital electronic circuitry and hardware 300) that adjusts andfocuses the fixation light in response to receiving a response from thetest subject. For example, as detailed below, the processor can beconfigured to receive a response, indicating whether the subject canclearly view the fixation light and/or the fixation dot 210 and, inresponse, adjust the position of the fixation light source Sf to bringthe fixation light in focus for the subject.

Similarly, the LED, OLED, and/or LCD light sources, when used as ableaching light source SB, can be configured to move (e.g., in responseto feedback signals provided by an eye-tracking mechanism, as detailedbelow with reference to FIG. 2A), in line with the subject's eye, toachieve alignment with the subject's eye(s). For example, in someembodiments, the bleaching light source SB can be moved in line with thesubject's eye through two-dimensional movements in the X-Y plane.Specifically, as shown in FIG. 2B, the bleaching light source SB can beconfigured to move, in the direction shown by arrow m2 and/or in thedirection shown by arrow m3, in front of the source that generates thestimulus and fixation lights Sf. This configuration allows the bleachinglight source SB to provide the light beams required to bleach thephotoreceptors in the subject's eye(s). Once the bleaching sequenceduration is complete, the bleaching source SB can in order to allowexposure of the subject's eye to the fixation and/or stimulus lightsemitted by the fixation and/or stimulus light source(s) Sf.

The fixation and stimulus LED, OLED, and/or LCD light source screens canmove in connection with real-time eye tracking. Specifically, thefixation and/or stimulus light source(s) Sf can be configured such thatthey move, in response to information received from a real-time eyetracking mechanism (e.g., a pupil tracking mechanism) to follow thelocation of a subject's eye/pupil. As shown in FIG. 2C, the LED, OLED,and/or LCD light source screens can move in any number of positionswithin the XY plane, for example in the directions shown using arrowsa1, a2, a3, a4, . . . , an−1, an, where n is a finite number.

FIG. 2D schematically illustrates the manner in which a subject's eyecan be exposed to an LED, OLED, and/or LCD light source screen. Asshown, the screen T of a light source Sf can be positioned in front ofthe subject's eye to provide the subject's eye 240 with a direct line oflight DL (e.g., a direct line of stimulus light). FIG. 2D alsoillustrates the cosine angle C for correcting stimulus intensityaccording to the degree of misalignment of the subject's eye relative tothe light source. As noted above, cosine correction techniques can beused to ensure that appropriate stimulus light levels are directed atthe eye, regardless of the angle of alignment between an LED/OLED/LCDpixel source and the subject's eye.

Further, as shown in FIG. 2E, the curvature of the LED, OLED, and/or LCDlight source screen T can be used to accommodate eye wander with lesscorrection for intensity. Specifically, as shown in FIG. 2E, a concavespherically-curved OLED screen Ts with its center point aligned at theeye/pupil of the subject, can be used to accommodate eye wander withouta need to correct for intensity. The concave spherically-curved OLEDscreen Ts ensures that the subject's gaze is aligned and remains withinthe coverage range of the beams emitted by the OLED screen Ts , therebyensuring that appropriate amounts of light are directed at the subject'seye at all times.

Referring back to FIG. 2A, the optical system 200 can further compriseone or more optical components (collectively referenced using referencecharacter O) that are configured to direct the light beams emitted bythe light source S to the subject's eye 240. The optical components canbe configured such that they direct the light beams emitted by the lightsource S to any suitable portion of the subject's eye, for example thepupil and/or the retina of at least one eye 240 of the test subject.

The optical components O can generally include any suitable opticalelements available in the art. For example, the optical components O cancomprise at least one lens 206 that is optically coupled to the lightsource S and configured to collimate the light beams emitted by thelight source S. The lens 206 can comprise at least one aspheric lens 206adapted to correct for spherical aberration.

Additionally or alternatively, the optical components O can include oneor more mirrors 207 that are configured to redirect the light beamsemitted by the light source S as needed. For example, the one or moremirrors 207 can be configured to direct the light emitted by the testlight source onto a test subject's eye. The one or more mirrors 207 cancomprise at least one dichroic mirror that is configured to reflect thelight from the test light source S onto the subject's pupil and allowpassage of the light returning from the subject's eye into the opticalsystem 200. As detailed below, the light source S can comprise aninfrared light source configured to illuminate at least one eye of thesubject. The one or more mirrors 207 can comprise at least one dichroicmirror that is configured to reflect the light from the infrared lightsource onto the subject's pupil and allow passage of the light returningfrom the subject's eye into the optical system 200 and an infrared lightdetector IR_(D) (discussed below). By way of example, the infrared lightcan have a wavelength of greater than about 700 nanometers.

In some embodiments, the light source S and/or the optical components Ocan be housed in a sealed package 204. The sealed package 204 can be anintegral part of the optical system 200 or can be configured such thatit is removably and replaceably mounted within the optical system 200 toprovide for removal and/or replacement of the optical components O.

The optical system 200 can further comprise one or more mechanisms 208for controlling the movements of the light source S and/or the opticalsystem O. Specifically, the light source S and/or the optical componentsO can be coupled with one or more mechanisms 208 that move and/or rotatethe light source S and/or the optical components O within the housing201 of the optical system 200 and/or within the frame 102 of the headset102. For example, as noted above, the one or more mechanisms 208 can becoupled to and/or controlled by a processing circuitry that moves and/orinstructs movement of the light source S and/or the optical components Oin response to receiving real-time information regarding the location ofthe subject's pupil(s) and/or in response to information or feedbackreceived from the subject. In some embodiments, the one or moremechanisms 208 can comprise one or more moveable platforms 202, 203 onwhich the light source S and/or the optical components O are mounted.The platforms 202, 203 can be movable and configured such that theyallow movements of the light source S and/or the optical components Owithin the optical system 200, relative to the housing 201 of theoptical system 200 (and/or within the headset 102 of the optical testingsystem 100). In some embodiments, the platforms 202, 203 can be movablealong at least two orthogonal directions for aligning the light source Srelative to the pupil of the subject's eye 240. Additionally oralternatively, the platforms 202, 203 can be fixedly positioned relativeto the housing 201 and/or the headset 102.

Further, the one or more mechanisms 208 can be coupled to a dial or aknob 218/118 (FIG. 1A) that is configured to engage the one or moremechanisms 208 to move the light source S and/or the optical componentsO. The dial 218 can be configured such that it can be rotated by a user.A cam 219 can be coupled to the dial 218 and configured to transform therotational motion of the knob/dial 218 to linear translation of thelight source S and/or the optical components O.

Alternatively or additionally, the mechanism for moving the fixationlight can comprise a motor 220 (e.g., stepper motor), such as anelectrically controlled motor. The motor can be configured such that itcan be controlled in response to at least one of a user's input of arefractive correction prescription, real-time user control of the lineartranslation of the fixation light, and/or in response to instructionsreceived from a processor included in the digital circuitry 300 of theophthalmic testing system.

The optical system 200 can further comprise an automated pupil trackingmechanism 205 that is configured to align and/or adjust the positionand/or orientation of the light source S and/or the optical componentsO, relative to the pupil of the subject's eye 240. The automated pupiltracking mechanism 205 can include a light source (e.g., a visible lightsource or an infrared light source) IR_(S) and a light detector (e.g., acamera, a light detector or camera capable of detecting visible light,an infrared light detector, or an infrared camera) IR_(D). The lightdetector IR_(D) can be a camera that is configured to generate an imageof the subject's pupil based on the light returning from the at leastone eye 240 of the subject. The light source IR_(S) can be configuredsuch that it illuminates the subject's eye 240. A portion of the lightincident on the subject's eye is reflected and returned to the automatedpupil tracking mechanism 205. The light detector IR_(D) detects thereturned light and determines the position and/or size of the pupil ofthe subject's eye 240 based on the detected returned light.

In some embodiments, the light source IR_(S) can generate the lightbeams, e.g., at a wavelength greater than about 700 nm for illuminatingthe subject's eye. Further, as shown in FIG. 2A, the optical system 200can comprise a mirror mi, which can be a dichroic mirror. The dichroicmirror can be configured to reflect the visible light generated by thelight source S, IR_(S). The dichroic mirror can also allow the passageof the light returning from the subject's eye, in response to beingilluminated by the light source S/IR_(S) and/or direct the reflectedlight to the light detector IR_(D).

The light detector IR_(D) can be mounted in any suitable position on theoptical system and/or at any suitable position within the headset 102(e.g., rear of the optics and/or behind the dichroic mirror m₁) andconfigured to detect and/or image the light passing through the dichroicmirror mi and returning from the illuminated eye.

As noted above, the automated pupil tracking mechanism 205 can becoupled to at least one of the light source S, the optical components O,and/or the platform(s) 202, 203 and configured such that it aligns atleast one of these elements with the pupil of the subject's eye 240. Theautomated pupil tracking mechanism 205 can further comprise a feedbacksystem (described below with reference to FIG. 6) and be configured suchthat upon placement of the ophthalmic testing system 200 against asubject's eye 240, it automatically detects the position and/or size ofthe pupil of the subject's eye 240, and, in response, aligns at leastone of the light source S, the optical components O, and/or theplatform(s) 202, 203 to the pupil of the subject's eye 240.

Generally, any suitable mechanisms for tracking a subject's eye or pupilcan be employed in practice of the embodiments disclosed herein. By wayof example, in some embodiments, an eye tracking mechanism similar tothat disclosed in published PCT application number US/2006/062557,entitled “Pupil Reflection Eye Tracking System And Method,” and hereinincorporated by reference in its entirety, can be employed. Withreference to FIG. 2F, such an eye-tracking mechanism 9 can include anillumination source 17 (e.g., source IR_(S) shown in FIG. 2A), which canemit radiation having one or more wavelengths in the infrared ornear-infrared portions of the electromagnetic spectrum, e.g., at awavelength below 1.5 microns. A variety of illumination sources, such aslight-emitting diodes (LEDs), can be employed. The illumination source17 can be configured to emit a beam of light having a diameter less thanthe pupil diameter, e.g., less than about 1 mm. A beam splitter 27 canbe positioned and configured to direct the light emitted by theillumination source 17 into a subject's eye and allow the lightreflected 12 from the subject's eye in response to the illuminationreach a detector 11.

The detector 11 (for example, detector IR_(D), shown in FIG. 2A) can beany suitable detector known in the art, for example a quadrant detectorthat is divided into quarters and has a plurality of concentric,substantially toroidal zones. The detector 11 can be configured toreceive radiation reflected from the retina 13 of the eye, defining aspatial extent of the pupil 14 of the eye, and generate data indicativeof the position of the received radiation on the detector 11. Thegenerated data can be transmitted to a processor 23 that containsappropriate software 24 for determining the position of the pupil fromthe obtained data.

The processor 23 can further process the detector data to select a zoneof the detector to use and/or to generate an error signal based on theratio of the detection signals from different detector zones. The errorsignal generated by the processor can then be transmitted to acontroller 25 that can adjust the bleaching and/or the stimulus lightsources (illumination source 17) so as to ensure substantial alignmentof the light emitted by these light sources with the subject's pupil.The controller 25 can also receive control signals from the processor23, and based on the control signals, control various elements of thesystem, such as the optical elements 31, 32 (e.g., mirrors and lenses)positioned downstream of the source 17 and/or upstream of the pupil 14.

Further, as shown in FIG. 2A, a controller 210 can be in communicationwith the detector IRD to receive electrical signals generated by thedetector IRD in response to the detection of the infrared radiationreturning from the subject's eye 240. The controller 210 can beconfigured to determine the relative alignment of the source IRS withrespect to the pupil of the subject's eye 240. More specifically, thecontroller 240 can operate on the electrical signals generated by thedetector IRD to generate an error signal, whose magnitude is indicativeof the degree of misalignment between the infrared source IRS and thesubject's pupil.

If the error signal generated by the controller is greater than apredefined threshold, the controller 240 can cause the movement of themovable platforms 202, 203 to minimize the error signal, therebybringing the source S in substantial alignment with the subject's pupil.As the light source S, generating the bleaching light, the stimuluslight, as well as the fixation light, is fixedly positioned on theplatform 202, 203, it can move on the platform, relative the subject'spupil, and result in substantial alignment of the light source Srelative to the subject's pupil.

The movable platform 203, 203′ upon which the lens is mounted cancomprise an automatic alignment mechanism that is configured tocontinuously align the optics relative to the light sources to directthe light to the subject's pupil. The movable platform 203, 203′ can bemoved along three orthogonal dimensions, which are designated herein asX, Y, and Z dimensions. The Z-dimension is chosen to be along thedirection of the light propagation and the X and Y dimensions areorthogonal to the Z-direction. The movable platform 203, 203′ can bemoved along these dimensions to ensure that the direction of the lightpropagation is substantially aligned with the subject's pupil.

Referring back to FIG. 2A, the infrared light source IR_(S) and theinfrared light detector IR_(D) of the pupil tracking mechanism 205 canbe disposed on any suitable position in the housing 201 and/or theheadset 102, such as adjacent to the optical interfaces 122L, 122R,adjacent to the transparent windows 123L, 123R, adjacent to the lightseals 124L, 124R, on the wall of the rear housing inside the eye chamberincluding the rear housing, eye cups, and/or on the disposable lightseal, adjacent to the eye.

Further, embodiments disclosed herein can generally employ any suitabletechnique for operating on the detected signals and arriving at a degreeof alignment of the light source relative to the subject's pupil.Moreover, upon the detection of a misalignment of the light sourcerelative to the subject's pupil, the controller 210 can cause themovement of the movable platforms 202, 203 via a feedback loop to bringthe light source S and/or the optical components 0, in substantialalignment relative to the subject's pupil. More specifically, in someembodiments, the controller 110 can actuate various means (e.g., motors)for moving the movable platforms 202, 203 along X, Y and Z axes.

Further, during the performance of an ophthalmic test, the alignmentmechanism 205 can continuously track the position of the subject's pupiland continuously correct for any misalignment of the light sourcesrelative to the subject's pupil. In this manner, the alignment mechanismcan correct, for example, for involuntary movements of the subject'seye, vibrations and other unwanted motions of the optical system, amongothers.

In some embodiments, the pupil(s) of the subject's eye(s) can be dilatedprior to using the ophthalmic testing system 100 disclosed herein. Theautomated pupil tracking mechanism 205 can be configured to correct forthe subject's pupil size and for any changes induced in the subject'spupil(s). The automated pupil tracking mechanism 205 can also providethese corrections in real time. Alternatively or additionally, the pupiltracking mechanism 205 can be configured to correct for the position ofthe subject's upper and/or lower eye lids and/or eyelashes in correctingfor and determining the subject's pupil size or position. Further, incorrecting for the subject's pupil size, the ophthalmic testing system150 can adjust the intensity of the stimulus and/or the bleaching lightsapplied to the subject's eye. In other words, the ophthalmic testingsystem 150 can adjust the intensity of the stimulus and/or bleachinglights applied to the subject's eye based on the size of that subject'spupil(s).

Although not described herein, the optical system 200 can generallyinclude any components required for conducting its intended functions.Non-limiting examples of the functions that can be provided by theoptical system 200 include functions required for performing FundusRetinal Imaging, Retinal Densitometry, Optical Coherence Tomography(OCT), Fluoroscein Angiography, OCT Angiography (OCTA), Multi-spectralImaging, Scanning Laser Ophthalmoscope, Anterior Segment OCT, Deep-fieldOCT, Retinal Metabolic Imaging, Ocular Blood Flow Imaging, AdaptiveOptics, Autofluorescence, Non-mydriatic Fundus Camera, Optic NerveImaging, Ultrasound, Anterior Segment Photography, Slit Lamp, andRefractive Eye Care testing including functions of a Pachymeter andInterior Segment testing functions.

FIG. 3 is a high-level block diagram of digital electronic circuitry andhardware 300 that can be used with, incorporated in, or fully orpartially included in an ophthalmic testing and measurement systemaccording to the embodiments disclosed herein. The electric circuitry300 can include a processor 310 that is configured to monitor theoperation of the ophthalmic testing system, send and/or receive signalsregarding the operation of the ophthalmic testing system, and/or controlthe operation of the ophthalmic testing system.

The processor 310 can be configured to collect or receive informationand data regarding the operation of the ophthalmic testing system 150and/or the head-wearable device 100 and/or store or forward informationand data to another entity (e.g., another portion of an ophthalmictesting system, etc.). The processor 310 can further be configured tocontrol, monitor, and/or carry out various functions needed foranalysis, interpretation, tracking, and reporting of information anddata collected by the ophthalmic testing system 150 (for example, asimplemented in the head-wearable device 100 shown in FIG. 1A).Generally, these functions can be carried out and implemented by anysuitable computer system and/or in digital circuitry or computerhardware, and the processor 310 can implement and/or control the variousfunctions and methods described herein.

The processor 310 can further be generally configured to monitor theoperation of the ophthalmic testing system 150, send and/or receivesignals regarding the operation of the system 150, and/or control theoperation of the system 150. The processor 310 can also collect orreceive data regarding the operation of the system 150 and/or store orforward the data to another entity (e.g., a medical facility, etc.).

The processor 310 can be connected to a main memory 320, and comprise acentral processing unit (CPU) 315 that includes processing circuitryconfigured to manipulate instructions received from the main memory 320and execute various instructions. The CPU 315 can be any suitableprocessing unit known in the art. For example, the CPU 315 can be ageneral and/or special purpose microprocessor, such as anapplication-specific instruction set processor, graphics processingunit, physics processing unit, digital signal processor, imageprocessor, coprocessor, floating-point processor, network processor,and/or any other suitable processor that can be used in a digitalcomputing circuitry. Alternatively or additionally, the processor cancomprise at least one of a multi-core processor and a front-endprocessor.

Generally, the processor 310 and the CPU 315 can be configured toreceive instructions and data from the main memory 320 (e.g., aread-only memory or a random access memory or both) and execute theinstructions. The instructions and other data can be stored in the mainmemory 320. The processor 310 and the main memory 320 can be included inor supplemented by special purpose logic circuitry. The main memory 320can be any suitable form of volatile memory, non-volatile memory,semi-volatile memory, or virtual memory included in machine-readablestorage devices suitable for embodying data and computer programinstructions. For example, the main memory 320 can comprise magneticdisks (e.g., internal or removable disks), magneto-optical disks, one ormore of a semiconductor memory device (e.g., EPROM or EEPROM), flashmemory, CD-ROM, and/or DVD-ROM disks.

The main memory 320 can comprise an operating system 325 that isconfigured to implement various operating system functions. For example,the operating system 325 can be responsible for controlling access tovarious devices, memory management, and/or implementing variousfunctions of the optical testing system 150. Generally, the operatingsystem 325 can be any suitable system software that can manage computerhardware and software resources and provide common services for computerprograms.

The main memory 320 can also hold application software 327. For example,the main memory 320 and application software 327 can include variouscomputer executable instructions, application software, and datastructures, such as computer executable instructions and data structuresthat implement various aspects of the embodiments described herein. Forexample, the main memory 320 and application software 327 can includecomputer executable instructions, application software, and datastructures, such as computer executable instructions and data structuresthat implement a subject-instruction system (e.g., an automatedsubject-instruction system, as detailed below), which can be employed tocommunicate with the subject in order to, for example, instruct thesubject during an ophthalmic test.

Generally, the functions performed by the ophthalmic testing system 150can be implemented in digital electronic circuitry or in computerhardware that executes software, firmware, or combinations thereof. Theimplementation can be as a computer program product (e.g., a computerprogram tangibly embodied in a non-transitory machine-readable storagedevice) for execution by or to control the operation of a dataprocessing apparatus (e.g., a computer, a programmable processor, ormultiple computers).

The main memory 320 can also be connected to a cache unit (not shown)configured to store copies of the data from the most frequently usedmain memory 320. The program codes that can be used with the embodimentsdisclosed herein can be implemented and written in any form ofprogramming language, including compiled or interpreted languages, andcan be deployed in any form, including as a stand-alone program or as acomponent, module, subroutine, or other unit suitable for use in acomputing environment. A computer program can be configured to beexecuted on a computer, or on multiple computers, at one site ordistributed across multiple sites and interconnected by a communicationsnetwork, such as the Internet.

The processor 310 can further be coupled to a database or data storage330. The data storage 330 can be configured to store information anddata relating to various functions and operations of the ophthalmictesting and measurement system 150. For example, the data storage 330can store the data collected by the ophthalmic testing and measurementsystem 150. Further, in some embodiments, the database 330 can beconfigured to store information regarding detected events that may be ofinterest to the authorized party. For example, as detailed below, thedatabase 330 can be configured to store the number of detected suddenacceleration or deceleration events that occur in the head-wearabledevice 100 implementation of the ophthalmic testing and measurementsystem 150 over a time period.

The processor 310 can further be coupled to a display 317 (e.g., display117 shown also in FIG. 1A). The display 370 can be configured to receiveinformation and instructions from the processor. The display 370 cangenerally be any suitable display available in the art, for example aLiquid Crystal Display (LCD) or a light emitting diode (LED) display.For example, the display 370 can be a smart and/or touch sensitivedisplay that can receive instructions from a user and/or provideinformation to the user.

The processor 310 can further be connected to various interfaces. Theconnection to the various interfaces can be established via a system oran input/output (I/O) interface 349 (e.g., Bluetooth, USB connector,audio interface, FireWire, interface for connecting peripheral devices,etc.). The I/O interface 349 can be directly or indirectly connected tothe ophthalmic testing system 150.

The processor 310 can further be coupled to a communication interface340, such as a network interface. The communication interface 340 can bea communication interface that is included in the ophthalmic testing andmeasurement system 150 and/or a remote communications interface 340 thatis configured to communicate with the ophthalmic testing and measurementsystem 150. For example, the communications interface 340 can be acommunications interface that is configured to provide the ophthalmictesting and measurement system 150 with a connection to a suitablecommunications network 344, such as the Internet. Transmission andreception of data, information, and instructions can occur over thecommunications network 344. Further, in some embodiments, thecommunications interface 340 can be an interface that is configured toallow communication between the digital circuitry 300 (e.g., a remotecomputer) and the ophthalmic testing and measurement system 150 (e.g.,via any suitable communications means such as a wired or wirelesscommunications protocols including WIFI and Bluetooth communicationsschemes).

FIG. 4A is a high-level block diagram of a system 400 according to someembodiments disclosed herein. In the example shown in FIG. 4A, theophthalmic testing and measurement system 450 comprises an interfaceunit 460 that is configured to 1) receive instructions for operating theophthalmic testing and measurement system 450 from a provider/clinicianproviding an ophthalmic test to a test subject and 2) receive a responsefrom the subject.

Specifically, as shown in FIG. 4A and described previously in connectionwith FIGS. 1A-3, the ophthalmic testing system 450 can be implemented ina headset 402 of a head-wearable device and configured to receive atleast one eye 440 of the subject. The ophthalmic testing system 450 cancomprise an optical system 200 that includes the various componentsneeded to conduct the ophthalmic tests and measurements disclosed hereinand the digital electronic circuitry and hardware 300 for implementingvarious functions of the ophthalmic testing system 450. As explained inrelation to FIG. 3, the digital electronic circuitry and hardware 300can comprise a processor 310, an I/O interface 349, and a communicationsinterface 340. The I/O interface 349 can be directly or indirectlyconnected to the ophthalmic testing system 450 and configured to couplethe ophthalmic testing system 450 with various interfaces. For example,as noted above, the I/O interface 349 can couple the ophthalmic testingsystem 450 to an RFID reader 427. The RFID reader 427 can be any RFIDreader known in the art. In the head-wearable implementation of theophthalmic testing system (e.g., FIG. 1A), the RFID reader 427 cancomprise an interface 427i that is positioned at any suitable locationon the external surface of the head-wearable device.

The RFID reader 427 can be configured to provide asset tracking (e.g.,asset tracking of disposables) and ensure that only systems, equipment,and/or parts produced by original equipment manufacturer (OEM) are usedwith the ophthalmic testing system 450. For example, as noted above, theRFID reader 427 can be configured to ensure single usage ofdisposable/hygienic covers used to cover the light seals 124 used toisolate the subject's eyes from ambient light.

As described above, in some embodiments, a cover 425 having an RFID tag426 (e.g., a passive RFID tag) can be used with the light seal. The RFIDtag 426 can be configured to enforce single usage of the disposablecover 425. For example, the ophthalmic testing system 450 can beconfigured such that it can only be used to conduct a test once the RFIDtag 426 of the cover is scanned against the RFID reader 427 (e.g., bybringing the RFID tag 426 in the vicinity of the interface 427i of theRFID reader 427). Although described in terms of an RFID tag 426 and anRFID reader, one having ordinary skill in the art should appreciate thatany tracking system known/available in the art can be used for assettracking and management with the embodiments disclosed herein. Forexample, a barcode 426 can be coupled to the cover and configured to betracked by a barcode reader 427. Further, in addition to the cover 425,any other part or portion of the ophthalmic testing system 450 cancomprise a tracking mechanism, such as an RFID tag and/or a barcode.

As noted, the tracking mechanism 427 (e.g., RFID reader or barcodereader, hereinafter generally referred to as “RFID reader”) can becoupled to a processor 310 of the digital circuitry 300 of theophthalmic testing system 350 directly or indirectly (e.g., through anI/O interface 349). The RFID reader 427 can be configured such that uponscanning an RFID tag 426 (or a barcode or an OCR code, hereinaftergenerally referred to as “RFID tag”), the RFID reader sends theinformation stored in the RFID tag 426 to the processor 310 forprocessing. The processor 310 processes the information and determineswhether the information on the RFID tag 426 corresponds to an RFID tagrecorded on an original manufacturer's disposable. For example, thedatabase 330 (FIG. 3) of the ophthalmic testing system 450 can comprisea listing of information stored on RFID tags of consumables/parts knownto have been manufactured by the original manufacturer of the ophthalmictesting system 450. Upon receiving the information included on a scannedRFID tag, the processor 310 can check the information on the scannedRFID tag against the information in the database 330 to determinewhether a match exists. If a match is found, the processor 310 acceptsthe RFID tag 426 and the consumable 425 as an RFID tag 216 andconsumable belonging to the original manufacturer. The processor 310 canalso allow an operator/clinician operating the ophthalmic testing system450 to conduct a test on the subject, and/or the subject herself, toprovide identifying information that can be used to uniquely identifythat test subject. As detailed below, the identifying information caninclude any suitable information known and/or available in the art, forexample, name, medical record number, biometric information, etc.

As noted above, the ophthalmic testing and measurement system 450 cancomprise a interface unit 460 that is configured to 1) receiveinstructions for operating the ophthalmic testing and measurement system450 from a provider/clinician administrating an ophthalmic test to atest subject and 2) receive a response from the subject. In someembodiments, the interface unit 460 can comprise one or more navigationkeys configured to allow the provider and/or the clinician to initializeand/or conduct the ophthalmic test at hand. For example, as shown inFIG. 4A, the interface unit 460 can comprise one or more keys 461, 462,463, 464 configured to provide the clinician with the ability to move acursor on the screen in the vertical (up and down) and horizontal (leftand right) directions. It should be noted that although described ashaving four keys 461, 462, 463, 464, the interface unit 460 can includeany number of keys and provide the clinician with motion in any suitabledirection. Further, the provider can move the cursor on the screen inany suitable number of directions, for example the interface can providea five-way motion of the cursor on the screen.

Further, the display 407 of the ophthalmic testing and measurementsystem 450 can be configured to allow the clinician to initialize thetest and/or facilitate the testing process. Specifically, as shown inFIG. 4A, the display 407 of the ophthalmic testing system 450 can beconfigured to provide the clinician with one or more menus for use ininitializing and/or conducting an ophthalmic test. For example as shownin FIG. 4A, the display 402 can comprise a menu 407m that allows theclinician to select at least one eye 440R, 440L of the subject forconducting the test. Once an eye 440R is selected, the display 407 canpresent the clinician with another menu for selecting a test to performon the subject selected eye 440R. In some embodiments, the display 407can allow the clinician to conduct the same or two different tests onthe subject's eyes. Further, the display 407 can provide the clinicianwith the option of conducting more than one test on an eye 440R of thetest subject. The tests conducted on the subject's eye(s) can beadministered concurrently, in parallel, and/or at different times duringthe testing process.

Once an eye for testing and one or more tests for conducting on that eyeare selected, the display 407 can provide the clinician with informationregarding the test, for example time lapsed and/or expected timeremaining for completion of the test. For example, as shown in FIG. 4A,the display 407 can provide the clinician with the time remaining 440Rt,440Lt for completion of the test(s) on each eye 440R, 440L of thesubject.

As noted, the display 407 is coupled to the processor and configured toprovide and/or receive information from the processor 310. The processor310 and the digital circuitry 300 of the ophthalmic testing system 450are also coupled to the optical system 200 and configured to controland/or adjust the optical system 200 to provide a test selected on thedisplay 407 of the ophthalmic testing system 450. This arrangementallows a clinician operating the interface unit 460 to remotely, andwithout directly coming in contact with the ophthalmic testing system450, which may be mounted on a subject's head (in a head-wearableimplementation), control the operation of the ophthalmic testing system450.

FIG. 4B is a high-level block diagram of an interface unit 460 accordingto some embodiments disclosed herein. The interface unit 460 can includedigital circuitry and hardware for conducting and performing variousfunctions of the interface unit 460. The digital circuitry can comprisesimilar elements as those described with reference to FIG. 3.Specifically, the interface unit 460 can comprise a processor 410 thatconnects to a communication interface 440 and an I/O interface 449. TheI/O interface 449 can be coupled to various I/O interface devices thatcan receive instructions from the provider/clinician and subject (suchas input keys 461, 462, 463, 464, 465), an audio input element 466 (suchas a microphone), an audio output element 467 (such as a speaker), adisplay 468 (such as an interactive display), and other input/outputinterface devices 469.

It should be understood that although shown a separate unit in FIG. 4A,the interface unit 460 can be an integral part of the ophthalmic testingsystem 450 and located on board of the ophthalmic testing system (e.g.,on a tabletop device and/or implemented in a head-wearable device).Further, the interface unit 460 and the ophthalmic testing system 450can comprise a single processing circuitry responsible for conductingthe functions of the interface unit 460 and the ophthalmic testingsystem 450.

The audio input element 466 can generally comprise any suitable audioinput element known in the art. Generally, any suitable number of audioinput elements can be used. For example, the interface unit 460 cancomprise one or more microphones 456. The one or more audio inputelements 466 can be configured to receive audio input from the testsubject, the clinician, or from the testing area surrounding the subjectand clinician (e.g., from the subject and/or individuals conducting theophthalmic test(s)).

In some embodiments, an audio input element 466 (e.g., microphone) canbe configured to receive responses of the test subject to the ophthalmictest being performed on the subject. The audio obtained from the testsubject (or other individuals) can be forwarded to the processor 410 ofthe interface unit 450 for analysis and processing. Alternatively oradditionally, the audio input can be forwarded to the processor of theophthalmic testing unit 450 and/or to the processor of another componentor device for processing or analysis.

In some embodiments, the audio obtained from the test subject can beforwarded to the processor for processing for analysis and processing.Upon processing, the processor can use the information obtained from thesubject to issue instructions to the subject, carry out the test, and/ormake appropriate adjustments to the test.

The audio input element 466 can be disposed in any suitable location onor within the ophthalmic testing system 450 and/or at any locationwithin the head-wearable device. For example, the one or more audioinput element 466 can be disposed on any suitable position on thehead-mount 103 (e.g., adjacent to or in the vicinity of the subject'sear), incorporated in the head-mount 103, incorporated in the headset102, and/or placed at any desired or suitable location in the vicinityof the ophthalmic testing system 450 (e.g., in the exam room).

The interface unit 460 can further include one or more audio speakers467, which may be connected to the processor 410 via the I/O unit 449.The one or more speakers 467 can be any suitable audio speaker availablein the art and can be disposed in any suitable location on or within theophthalmic testing system 450. For example, the one or more audiospeakers 467 can be disposed on any suitable position on the head-mount103 (e.g., adjacent to or in the vicinity of the subject's ear),incorporated in the head-mount 103, incorporated in the headset 102,placed at any desired or suitable location in the vicinity of theophthalmic testing system 450 (e.g., in the exam room), and/or becoupled with the ophthalmic testing system 450 using a wired or wirelessconnection.

The audio speakers 467 can be configured such that they can be used tocommunicate (e.g., via audio communication) with the subject. Forexample, as discussed in further details below, the ophthalmic testingsystem 450 can include a sub-instructor, implemented by the processor(e.g., implemented in the application software 327) that is configuredto communicate with the test subject via the audio speakers 467. Thespeaker(s) 467 can be utilized to provide verbal/audio commands andinstructions to the subject and/or inform the subject of the status ofthe ophthalmic test. The verbal instructions can be issued by theprocessor and/or by a clinician or a by a medical professional (orthrough an automated system). Additionally or alternatively, the audiospeakers 467 can be used to provide background music, sounds, orcomments (encouraging comments, comments regarding the test, etc.) tothe subject in order to improve focus and attention during the test inorder to reduce fixation error, error rates and/or failed tests.

As noted, the audio speaker 467 can be configured such that they can beused to communicate (e.g., via audio communication) with the subject.For example, the audio speaker 467 can be configured such that they canbe utilized by a medical professional (or through an automated system)to provide verbal/audio commands and instructions to the subject and/orinform the subject of the status of the ophthalmic test.

The audio input 466 and output 467 systems (speakers and microphonesdescribed herein) can be coupled to the ophthalmic testing system 450using any suitable means known in the art. For example, the audio inputand/or output systems can connect to the system 450 using a wirelessand/or Bluetooth functionality. In some embodiments, the audio inputand/or output functionality can be provided through a wireless headset(e.g., a wireless or a Bluetooth headphone). The audio speaker 467and/or any audio input 466 system (microphone) used with the embodimentsdisclosed herein can generally be any suitable audio system known in theart. In some embodiments, the audio speaker 467 and/or any audio input466 system can comprise functionalities needed to reduce or cancelbackground noise. For example, the audio speaker 467 and/or any audioinput 466 system can comprise any suitable functionality available inthe art that can at least partially isolate the subject's hearing to theverbal guidance provided by system 450 and/or reduce background noise inthe audio input provided to the system.

The interface unit 460 can further include one or more displays 468,which can be coupled to the processor 410 via the I/O interface 449. Thedisplay(s) 468 can be configured to present relevant information to thesubject and/or receive information and/or control signals from thesubject and/or clinician. Further, the display 468 can be an interactivedisplay that is configured to receive information from the subjectand/or clinician.

Further, as shown in FIGS. 4C-4E, in addition to presenting/displaying avisual menu of the tests provided by the system 450, the display canalso provide/display updates regarding test status and progression (asdescribed above), possible errors, test results, and/or battery status449. For example, the display can provide information regarding possiblefixation (FIG. 4C) and/or bleaching (FIG. 4D) errors, progression andresults (FIG. 4C) of a Rod Intercept™ (RI™) offered by MacuLogix Inc.(Harrisburg, Pa., U.S.A).

Although not specifically shown in FIGS. 4A-4E, the display 407 can beconfigured to provide/display various functions, such as providinginformation regarding the status of the head-wearable system 100 and theheadset 102. For example, the display can be configured to display orprovide information as to whether the head-wearable system 100 has beensecurely placed against the subject's head, whether the headset 102 issecurely positioned against the subject's eyes 440R, 440L, whether thelight seal is sufficiently obstructing passage of light to the testsubject's eyes 140R, 140L, etc.

Further, although shown as a display that has been integrated in thesystem 450, it should be understood that the display can be directlyand/or indirectly coupled to the system 450. For example, as shown inFIG. 1A, the display 107 can be disposed on a front face 102F of theheadset 102 such that it covers at least a portion of the front face102F of the headset 102 and is visible, for example to an individualadministering an ophthalmic test. Alternatively or additionally, thedisplay 107 can be remotely coupled to the headset 102 using a wired orwireless connection.

In addition to receiving instructions and commands from theprovider/clinician, the interface unit 460 can also be configured toreceive instructions/responses/commands from the test subject.Generally, the response received from the test subject can be a responseprovided by the test subject in connection with one or more stimuliprovided by the ophthalmic testing system 450 to the test subject. Forexample, in some embodiments, the interface unit 460 can be configuredto receive a response from the subject once a subject recognizes astimulus light. Specifically, as noted above, the ophthalmic testingsystem 450 described herein can be configured to conduct a number oftests and measurements, including measurement of a subject's eye'sadaptation to darkness. This can be performed by bleaching a region ofthe subject's retina and subsequently presenting a stimulus light (e.g.,in the form of an image) having a lower intensity within the bleachedregion of the retina. Throughout the test, the subject is directed tofixate their gaze on a fixation light and provide a response when theyrecognize the stimulus light. The interface unit 460 can be configuredto receive the subject's response to the stimulus light.

In some embodiments, interface unit 460 can be configured such that itcan toggle between a clinician mode and a subject mode. Specifically,the interface unit 460 can be configured such that 1) it allows forusage of multiple keys and/or operation of a single key in multipledirections, while the interface unit 460 is in the clinician mode and 2)it can be switched to a single key and/or single button response keywhile the unit 460 is in a subject mode. This allows the system to placethe interface unit 460 in a clinician mode and use the multiple keysand/or multi-directional keys to set up and/or initialize the ophthalmictesting system 450. Once the test is ready to be conducted, the systemcan place the interface unit 460 in a subject mode and hand theinterface unit 460 to the subject for use in providing her response(e.g., to the stimulus light).

In some embodiments, the ophthalmic testing system 450 can be configuredsuch that the transition between the clinician and subject modes occursautomatically upon completion of the test setup on the ophthalmictesting system 450. Specifically, as shown in FIG. 4A-1, the cliniciancan use the multi-directional keys 461, 462, 463, 464, 465 on theinterface 460 to navigate through a menu 407m for initiating anophthalmic test using the ophthalmic testing system 450 describedherein. The menu can include multiple sub-menus and options 407 a, 407b, 407 c, through which the clinician navigates to initiate a test. Forexample, the clinician can use the interface 460 to select an eye of thesubject for performing a test (e.g., right eye, submenu 407 a),selecting a test (e.g., dark adaptation, submenu 407 b), and finalizesetting up the test (submenu 407 c). The clinician's selection can becommunicated to a processor (e.g., processor 310). The processor 310 cananalyze the received information and determine that the test has beeninitialized and is ready for being provided to the subject. At thattime, the processor 310 can communicate with the interface 460 (via theI/O interface 449 and a connection 443 (Bluetooth) and instruct theinterface 460 to switch from the clinician mode to the subject mode.While in the subject mode, the interface can no longer be used tocontrol the device and/or change the setup the ophthalmic test and canonly be used to provide a response to the system (e.g., response to astimulus light).

The processor 310 can monitor the subject's response to the test and/orthe progression of the test. Upon completion of the test, the processor310 can determine that the ophthalmic test is complete and, in response,instruct the interface 460 to transition back to the clinician mode.While in the clinician mode, the interface 460 can be used to issueinstructions and control the operation of the ophthalmic device 450.

In some embodiments, the transition between the clinician and testsubject mode can be controlled by the processor based on the manner inwhich the processor analyzes the signals received from the interface460. Specifically, the processor 310 can be configured such that itanalyzes the responses received from the multi-directional keys inaccordance with their intended direction as long as an ophthalmic testis not in progress. Specifically, if the processor 310 determines that atest is not in progress (e.g., while the clinician is navigating themenus to setup the test and/or is using the keys to read and/or deletetest results), it processes the responses received from themulti-directional keys based on their intended direction (upwardmotion/key is translated into upward motion on the screen, downwardmotion/key is translated into downward motion on the screen, etc.).However, once a test is fully setup and/or is in progress, the processor310 interprets any response received from the interface (regardless ofwhich motion/key is used) as a patient's response to the system (e.g., apatient response to a stimulus light)

Additionally or alternatively, in some embodiments, the clinician canemploy a key 486 on the interface unit 460 to switch the interface unit460 between the clinician and subject modes. Placing the interface unit460 in the subject mode can provide the subject with a single key forproviding her response, thereby reducing potential confusion for thetest subject and preventing the subject from altering the setup of thetest.

Further, it should be noted that although shown as different keys 461,462, 463, 464, 465, the interface unit 460 can comprise a single keythat can be toggled between being multi-directional (clinician mode) andsingle directional (subject mode). Moreover, the interface unit 460 cangenerally comprise any interface configured to receive a response fromthe test subject and/or receive instructions from theclinician/provider. As noted, the interface unit 460 can be coupled tothe I/O interface 349 of the digital circuitry 300 such that informationreceived by the interface unit 460 is directed, through the I/Ointerface 349 to the processor 310. Similarly, the interface unit 460can be configured to receive instructions from the processor 310 throughthe I/O interface 349. The connection between the interface unit 460 andthe I/O interface 349 can be established via any suitable communicationsprotocol/technique known in the art. For example, the connection betweenthe interface unit 460 and the I/O interface 349 can be established viawireless (Bluetooth) or a wired connection.

In some embodiments, the interface unit 460 can be a button or acomputer mouse that is pressed or clicked by the test subject every timethe subject observes a flash of light. Additionally or alternatively,the interface unit 460 can be an audio inlet configured to receiveverbal instructions from the test subject. For example, the interfaceunit 460 can receive verbal response from the test subject in the formof natural language. Further, the verbal responses can be variable innature or constrained to one, two, or more fixed words or statementsthat the ophthalmic testing system is programmed to accept.

As noted above, the processor 310 can employ biometric information ofthe subject to uniquely identify the test subject. In some embodiments,the ophthalmic testing system 650 can comprise a biometric interface 455that is configured for use in obtaining the biometric information of thetest subject.

FIG. 4E illustrates a high-level diagram of an interface 455 that can beused to obtain biometric information that identifies a test subject. Theinterface 455 can be coupled to the processor 310 of the ophthalmictesting system 450 (e.g., through the I/O interface 349) and configuredto forward biometric information obtained from the test subject to theprocessor 310. The processor can store the obtained information in thedatabase 330 of the digital circuitry 300 and/ use perform any othersuitable processing on the obtained information (e.g., match to alreadyexisting information in the database 330).

In some embodiments, the interface 455 can comprise a biometric scannerconfigured to obtain at least one biometric feature of the test subject.For example, the interface 455 can comprise a biometric scanner 456 thatis configured to obtain at least one of a facial feature of the testsubject 401, information obtained from an iris of the eye of the testsubject (e.g., using an iris scanner 458), information obtained from aretina of the eye of the test subject, and/or a fingerprint (using afinger print scanner 467) obtained from a finger 402 the test subject.

As noted, the interface 455 can forward the biometric informationobtained by the biometric scanner 456 to the processor 310 forprocessing and analysis. The processor 310 can use the biometricinformation to create a new profile for the test subject and/or accessan existing profile for the test subject 301. For example, the processorcan compare the obtained biometric information with biometricinformation previously stored in the database 330 to determine if aprofile for the test subject has been previously stored in the database.If a profile matching the biometric information exists, the processor310 can identify the test subject by matching his/her biometricinformation to the existing profile. If a profile for the test subjectis not identified, the processor can store the biometric information ofthe test subject, along with other information, such as name of the testsubject, address of the test subject, any identifiers associated withthe test subject, and health insurance information for the test subject,in a new profile for the test subject. Additionally or alternatively,the profile can be obtained from an electronic health record system,such as an electronic health record system that is maintained on acloud-based server. In such implementations, the processor 310 canaccess the subject's profile via the communication interface and thecommunications network. The processor can store a subject's profile inthe database 330 on the ophthalmic testing system 450 or a remotedatabase located at another location. Further, the processor 310 can beconfigured to receive and store, in the memory of the ophthalmic testingsystem, at least one medical history of the test subject, medicalinsurance information associated with the test subject, availablepretesting diagnostics information associated with the test subject.Alternatively or additionally, the processor 310 can be configured toreceive and store, in the memory of the ophthalmic testing system, atleast one medical history of the test subject, medical insuranceinformation associated with the test subject, and available pretestingdiagnostics information associated with the test subject.

FIG. 5A is a high-level block diagram of an ophthalmic testing system550 according to some embodiments disclosed herein. As noted, theophthalmic testing system 550 can be implemented in a table-top device,a device capable of being worn by a test subject, and/or a devicecapable of being placed against the subject's head and/or face such thatat least a portion of the device is disposed adjacent or against atleast one eye of the subject (generally referred herein as a“head-wearable device”).

The ophthalmic testing system 550 can comprise one or more receptacles523R, 523L, each configured to receive at least one cartridge 500R,500L. Each cartridge 500R, 500L can comprise at least one optical systemhaving optical components for conducting various ophthalmic tests andmeasurements in accordance with the embodiments disclosed herein.Additionally or alternatively, each cartridge 500R, 500L can compriseother elements, such as digital electronic circuitry and hardware 300that can be used with, incorporated in, or fully or partially includedin an ophthalmic testing and measurement system according to theembodiments disclosed herein.

The ophthalmic testing system 550 can generally include any suitablenumber of receptacles 523R, 523L and can be configured to receive anysuitable number of cartridges 500R, 500L. For example, as shown in FIG.5A, the ophthalmic testing system 550 can comprise two receptacles 523R,523L, each configured to receive at least one cartridge 500R, 500L. Eachreceptacle 523R, 523L can be configured to receive the at least onecartridge 500R, 500L removably and replaceably.

The cartridge(s) 500R, 500L can be mounted and received by theophthalmic testing system 550 (within the housing of a tabletop deviceand/or in the headset 502 of a head-wearable device) via any suitablemeans known in the art. For example, each cartridge(s) 500R, 500L can bea removable and/or replaceable system that is configured such that itcan be inserted into and removed from the ophthalmic testing system 550through the receptacle(s) 523R, 523L. The cartridge(s) can further bereplaceable and configured such that upon removal from the frame 502 ofthe ophthalmic testing system 500, they can be replaced with one or moreother cartridges.

Each cartridge 500R, 500L can comprise a housing 550H. The housing 550Hcan include any suitable component known in the art and comprise anysuitable shape and/or material. For example, each cartridge 500R, 500Lcan be sized and/or shaped to ensure that the cartridge 500R, 500L canbe received by/fit into a corresponding receptacles 589R, 589L of theophthalmic testing system 550. In some embodiments, the receptacles589R, 589L can be configured such that they can receive cartridge(s)500R, 500L having a predetermined standardized shape and/or size.

Further, inn some embodiments, at least one interface 523R, 523L can beconfigured to receive a light seal 524R, 524L that is configured to sealan eye of the subject that is interacting with or engaged by theinterface 523R, 523L from ambient light. For example, an interface 523Rcan receive a light seal 524R that seals a corresponding eye 540R of thesubject from ambient light.

The ophthalmic testing system 550 can also comprise any suitablecomponent for receiving the cartridge(s) 500R, 500L. For example, asshown in FIG. 5B, the ophthalmic testing system 550 can include one ormore connections 513a (e.g., electrical connections) that are configuredto couple with one or more corresponding connections 513 b (e.g.,electrical connections) on the cartridge. Specifically, each cartridge500R can comprise one or more ports 513 b that are configured to couplewith one or more corresponding connections 513a in the receptacle 589 ofthe ophthalmic testing system 550. The corresponding ports andconnections 513 a, 513 b can be configured such that upon being coupledto one another they connect the cartridge 500R to the ophthalmic testingsystem 550 such that the components in the cartridge 500R can be usedwith the ophthalmic testing system 550 to provide ophthalmic testing andmeasurement. The ports and connections 513 a, 513 b can comprise anysuitable connection known in the art. For example, the ports andconnections 513 a, 513 b can comprise sockets, male and femaleelectrical and/or data connectors, USB ports and connectors, audio orvideo connectors, and/or any suitable connector available in the art.

Additionally or alternatively, the receptacles 589R, 589L and cartridges500R, 500L can have one or more electrical contacts (e.g., gold dots)configured to facilitate communication of operating instructions,drivers, automated sequencing, data, etc. between the cartridge 500R,500L and their components and the main operating system or firmware ofthe ophthalmic testing system 550. Further, as detailed below, thecartridge 500R, 500L can contain all the necessary hardware and softwarerequired to conduct the given ophthalmic test. Additionally oralternatively, the cartridge 500R, 500L can rely upon the components(e.g., optical components and/or digital circuitry) to some extent forboth hardware and software support to supplement aspects of the testfunction.

The cartridge(s) 500R, 500L and/or the receptacle(s) 589L, 589R canfurther include one or more locking mechanisms 514 a, 514 b configuredto lock a cartridge 500R in place once coupled to a correspondingreceptacle 589L, 589R. The locking mechanisms 514 a, 514 b can be anysuitable locking mechanisms known and available in the art. For example,in some embodiments, the cartridge(s) 500R, 500L can be configured toclick and lock into a corresponding receptacle 589L, 589R.

Additionally or alternatively, the cartridge(s) 500R, 500L and/or thereceptacles 189 can include one or more tracking systems 515 a, 515b,such as a radio frequency identification (RFID) tag or a barcode. Theone or more tracking systems 515 a, 515 b can be configured to provideasset tracking. For example, the cartridge(s) 500R, 500L and/or thereceptacle(s) 589R, 589L can include one or more tracking systems 515 a,515 b configured to ensure that only systems, equipment, and/or partsproduced by original equipment manufacturer (OEM) are used in theophthalmic testing system 550. Specifically, each of the cartridge(s)500R, 500L and the receptacle(s) 589R, 589L can include correspondingtracking systems 515 a, 515 b (e.g., barcodes, RFID tags) that areconfigured to only allow the cartridge(s) 500R, 500L produced by OEM tobe received by the receptacle 589R, 589L. In some embodiments, thetracking system 515a disposed on the receptacle 589R, 589L can be anRFID reader that is configured to read the information stored on apassive tracking system (RFID tag) 515 b disposed on a cartridge 500R,500L.

The tracking system 515a can be coupled to a processor (e.g., processor310 of the digital circuitry 300 of the ophthalmic testing system)directly or indirectly (e.g., through an I/O interface 349). The RFIDreader 515a can be configured such that upon scanning an RFID tag 515 b(or a barcode or an OCR code, hereinafter generally referred to as “RFIDtag”), the RFID reader sends the information stored in the RFID tag 515b to the processor for processing. The processor 310 processes theinformation and determines whether the information on the RFID tag 515 bcorresponds to an RFID tag recorded on an original manufacturer'sdisposable.

The cartridge(s) 500R, 500L can generally comprise any parts andconnections necessary for conducting ophthalmic tests and/ormeasurements. Further, the ophthalmic testing system 550 can begenerally configured such that it can receive cartridge(s) 500R, 500Lcapable of conducting any suitable ophthalmic tests and/or measurements.For example, ophthalmic testing system 550 can be configured to providevisual function testing using one or more cartridge(s) 500R, 500Lcapable of conducting a visual field test for detection of a disease orcondition, such as glaucoma. Alternatively or additionally, theophthalmic testing system 550 can be a system configured to receivecartridge(s) used for performing fundus retinal imaging, visual fieldtest, Frequency Doubling Technology Perimetry (FDT), Electroretinogram(ERG), Visual Evoked Potential (VEP), Contrast Sensitivity, ColorVision, Visual Acuity tests including: High luminance/High contrast, Lowluminance/High contrast, Low luminance/Low contrast, High luminance/Lowcontrast, Opotype, venier acuity, Reading Speed tests in High & lowluminance, Glare Testing (e.g., for cataract detection), MotionPerception, Metamorphopsia (e.g., in late AMD), Shape and TextureDiscrimination (e.g., in late AMD), Mesopic and Scotopic Visual Fields,Photostress, Microforimetry (Fundus-guided Forimetry), Tonometer,Sterio-opsis, Coneohistorhesis. These examples are non-limiting examplesof the tests and/or measurements that can be performed using theembodiments disclosed herein.

Further, the cartridge(s) 500R, 500L can be configured such that a givencartridge can be placed on either a left or a right receptacle 589R,589L for testing the right and/or the left eye of the subject. Further,the ophthalmic testing system 550 can be configured such that it canreceive two cartridge(s) 500R, 500L capable of conducting two differentoptical tests. The two different cartridge(s) 500R, 500L can provide theophthalmic testing system 550 with the capability to conduct a differenttest on each eye simultaneously or in parallel.

In some embodiments, depending on the tests provided by the cartridge(s)500R, 500L, one or more rules can be enacted to prevent right and leftcartridge(s) 500R, 500L from operating simultaneously, where falsepositive or false negative results or no results can be obtained fromhaving two different tests simultaneously. The one or more rules can beenacted in response to the nature of the tests or screens provided bythe cartridge(s) 500R, 500L. Rules governing and controllingsimultaneous test functions or simultaneous bilateral eye testing can beintegrated in the system to prevent the occurrence of test faults.Simultaneous test rules can require sequenced testing of each eyeindependently when it is deemed that the subject cannot accuratelyrespond to simultaneous stimulus presentation or other test interface.Additionally, each optical system can be configured to provide the testsubject with relevant automated instructions (instructions relevant tothe test provided by that optical system) to provide the test subjectwith active and responsive ontology guidance during the ophthalmictesting.

FIG. 5C illustrates an example of an ophthalmic testing system 550, asimplemented in a head-wearable frame 502, having similar components asthe head-wearable device shown in FIG. 1A. As shown, the frame 502 ofthe head-wearable device can include one or more receptacles or chambers589L, 589R configured to receive one or more cartridges 500L, 500R. Thecartridges 500L, 500R can be configured such that they seal thereceptacles 589L, 589R and the internal elements of the headset 502against the external environment.

In some embodiments, at least one cartridge 500R, 500L can be configuredas a light seal having components that are configured to seal thesubject's eye from ambient light. For example, a cartridge 500R cancomprise at least one material capable of having an adjustable opacityand/or a material configured to have an adjustable opacity in responseto a stimulus (e.g., illumination at certain light frequencies orintensities). In some embodiments, the material having adjustableopacity can comprise one or more polarized filters and/or one or moreliquid crystal layers.

FIG. 6 is a high-level block diagram of an embodiment of an ophthalmictesting system and measurement system 600 (“system 600”) according tosome embodiments disclosed herein. In one embodiment, the system 600 canbe configured to measure a subject's eye's adaptation to darkness. Thiscan be performed by bleaching a region of the subject's retina andsubsequently presenting a stimulus light (e.g., in the form of an image)having a lower intensity within the bleached region of the retina.Throughout the test, the subject is directed to fixate their gaze on afixation light and press a button when they recognize the stimuluslight.

The testing system 600 can comprise a frame 602 that is configured tohouse various components of the system. The frame 602 can comprise anoptical system (described with reference to FIG. 2) that comprises therequired optical components for conducting various ophthalmic tests andmeasurements with the embodiments disclosed herein, and digitalelectronic circuitry and hardware (described with reference to FIG. 3)that can be used with, incorporated in, or fully or partially includedin an ophthalmic testing and measurement system 650 according to theembodiments disclosed herein. It should be noted that although certainelements of the system 600 are shown as being inside or outside of theframe, the arrangement shown in FIG. 6 is a non-limiting example and thecomponents of the system 600 can be disposed in any suitable location,including within, on, or outside of the frame 602 of the system 600.

As described with reference to FIG. 2, the system 600 can comprise amechanism 601 for controlling the light source S and/or the opticalcomponents O. The mechanism 601 can include one or more platforms 603,603′, on which the light source S and/or the optical components O aremounted. The platforms 603, 603′ can be movable and configured such thatthey allow movements of light source S and/or the optical components Owithin the system 600 and relative to a frame 602 (and/or the frame ofthe optical system 612). For example, the platforms 603, 603′ can bemovable along at least two orthogonal directions for aligning the lightsource S relative to the pupil of the subject's eye 691. Additionally oralternatively, the platforms 603, 603′ can be fixedly positionedrelative to the frame 602.

The ophthalmic testing system 600 can further comprise one or moreoptical components (collectively referenced using reference character O)that are configured to direct the light beams emitted by the lightsource S to the pupil of a subject's eye. Further, in some embodiments,the optical components can be configured such that they direct the lightbeams emitted by the light source S to retina of at least one eye of atest subject. The optical components O can include any suitable opticalelements available in the art. For example, the optical components O cancomprise at least one lens 606 that is optically coupled to the lightsource S and configured to collimate the light beams emitted by thelight source S. The lens 606 can comprise at least one aspheric lens 606adapted to correct for spherical aberration. Additionally oralternatively, the optical components O can include one or more mirrors607 that are configured to redirect the light beams emitted by the lightsource S as needed. For example, as described in further details below,the one or more mirrors 607 can be configured to direct the lightemitted by the test light source onto a test subject's eye. The one ormore mirrors 607 can comprise a dichroic mirror that is configured toreflect the light from the test light source S onto the subject's pupiland allow passage of the infrared light returning from the subject's eyeinto the ophthalmic testing system 600 (e.g., an infrared light detectorIR_(D) discussed below). By way of example, the infrared light can havea wavelength of greater than about 700 nanometers.

Additionally or alternatively, the optical system 612 can include one ormore tracking systems 615, such as a radio frequency identification(RFID) tag or a barcode. The one or more tracking systems 615 can beconfigured to provide asset tracking. For example, the optical system612 can include one or more tracking systems 115 configured to ensurethat only systems, equipment, and/or parts produced by originalequipment manufacturer (OEM) are used in the ophthalmic testing system600. Specifically, each of the optical system 612 can includecorresponding tracking systems 615 (e.g., barcodes, RFID tags) that areconfigured to only allow optical systems produced by OEM to be used withthe system 600.

In some embodiments, the light source S and/or the optical components Ocan be housed in a sealed package 604. The sealed package 604 can be anintegral part of the optical system 612 or can be configured such thatit is removably and replaceably mounted within the optical system 612 toprovide for removal and/or replacement of the optical components O.

As noted, the mechanisms 601 for controlling the light source S and/orthe optical components O can further include one or more dials/knobs 699adapted to be rotated by a user and a cam system mechanically coupled tothe knob and configured to transform the rotational motion of the knobinto linear translation of the light source S. The one or more dials 699can be configured for use in adjusting a viewing distance of an imageplane provided by the headset. As described with reference to FIG. 1A,the knob or dial 699 can be used to manually adjust a fixation lightsource S. Specifically, the dial 118 can be connected to the fixationsource S_(f) and configured to move the fixation source in an axialdirection relative to the subject's eye(s). By moving the fixationsource S_(f) relative to the subject's eye(s), the dial 118 can bringthe fixation source S_(f) in focus and/or compensate for possiblereflective errors (e.g., nearsightedness (myopia), farsightedness(hyperopia), astigmatism or presbyopia) in the subject's eyes. The dial118 can be configured such that it can be adjusted by the test subjectand/or by the technician/clinician delivering the ophthalmic test to thesubject.

Generally, the light source S can be configured such that it is movablein one or more directions. Further, the light source S can be configuredto direct fixation lights emitted by the light source S out of the frame102 such that it brings the subject's attention to the light source S.The light source S can also be movable such that it brings the fixationlight into focus when viewed by the subject. Alternatively oradditionally, the light source S can be movable in a directionsubstantially along a propagation direction of the fixation lightemitted by the light source S.

As described with reference to FIG. 2F, the system 600 can furthercomprise an automated pupil tracking mechanism 605 that is configured toalign and/or adjust the position and/or orientation of the light sourceS and/or the optical components O relative to the pupil of the subject'seye 691. The automated pupil tracking mechanism 605 can be coupled tothe light source S, the optical components O, and/or the platform 601and configured such that it aligns at least one of these elements withthe pupil of the subject's eye 691. The automated pupil trackingmechanism 605 can further be configured such that upon placement of theophthalmic testing system 600 against a subject's eye 691, it canautomatically detect the position and/or size of the pupil of thesubject's eye 691, and, in response, align at least one of the lightsource S, the optical components O, and/or the platform 601 to the pupilof the subject's eye 691.

As noted above, the automated pupil tracking mechanism 605 can include alight source (e.g., a visible light source or an infrared light source)IR_(S) and a light detector (e.g., a camera, a light detector or cameracapable of detecting visible light, an infrared light detector, or aninfrared camera) IR_(D). The light detector IR_(D) can comprise a camerathat is configured to generate an image of the subject's pupil based onthe light returning from the at least one eye 691 of the subject. Thelight source IR_(S) can be configured such that it illuminates thesubject's eye 691.

A portion of the light incident on the subject's eye is reflected andreturns to automated pupil tracking mechanism 605. The light detectorIR_(D) can detect the returned light and determine the position and/orsize of the pupil of the subject's eye 691 based on the detectedreturned light. In some embodiments, the light source IR_(S) cangenerate light, e.g., at a wavelength greater than about 700 nm forilluminating the subject's eye. Further, as shown in FIG. 6 and detailedabove, a mirror mi, which can be a dichroic mirror, can be configured toreflect the visible light generated by the test light source S and allowthe passage of the light returning from the subject's eye in response toillumination by the light source from the test light source S. The lightdetector IR_(D) can be mounted in any suitable position on the frame 602(e.g., rear of the optics), behind the dichroic mirror mi, andconfigured to detect and/or image the light returning from theilluminated eye and passing through the dichroic mirror m₁.

As noted above, any suitable mechanisms for tracking a subject's eye orpupil can be employed with the embodiments disclosed herein. Further, insome embodiments, a controller 610 can be in communication with thedetector IRD to receive electrical signals generated by the detector IRDin response to the detection of the infrared radiation returning fromthe subject's eye 691. The controller 610 can be included on the frame602 and/or remotely coupled to the system 600.

The controller 610 can be configured to determine the relative alignmentof the source IRs with respect to the pupil of the subject's eye 691.More specifically, the controller 610 can operate on the electricalsignals generated by the detector IRD to generate an error signal, whosemagnitude is indicative of the degree of misalignment between theinfrared source IRs and the subject's pupil.

If the error signal generated by the controller is greater than apredefined threshold, the controller 610 can cause the movement of themovable platforms 603, 603′ to minimize the error signal, therebybringing the source S in substantial alignment with the subject's pupil.As the light source S (e.g., the light source that generates thebleaching light, the stimulus light, as well as the fixation light) isfixedly positioned on the platform 603, 603′, movement of the platform603, 603′ relative the subject's pupil can result in substantialalignment of the light source S relative to the subject's pupil.

The system 600 can further comprise a user interface (subject-responseinterface) 680 configured for use by the subject to provide the system600 with feedback in response to the ophthalmic test or measurementbeing conducted. The subject-response interface 680 can comprise anysuitable interface available in the art. For example, thesubject-response interface 680 can be a touch sensitive button, a pushbutton, a five-way rocker button, and/or a traditional computer mouse.The subject-response interface can be coupled with a response analyzer185 that is configured to analyze and assess the subject'sresponse/feedback received through the subject-response interface 680.For example, in one embodiment, the response analyzer 685 can beconfigured to analyze the feedback of the subject for assessing darkadaptation of at least one eye of the subject. The analyzer can includea processor (e.g., processor 310 shown in FIG. 3A) and a memory (e.g.,memory 320) coupled with the processor and configured to storeinstructions for analyzing the response of the subject (e.g., responseto a stimulus light in analyzing dark adaptation).

The infrared light source IR_(S) and the infrared light detector IR_(D)of the pupil tracking mechanism 605 can be disposed on any suitableposition in the housing 602, such as on the light seal 690, on the wallof the rear housing inside the eye chamber including the rear housing,eye cups, and/or on the disposable light seal, adjacent to the eye. AnRFID tag 698 can be incorporated in the light seal 690. The RFID tag 698can be coupled to the light seal 690 in any suitable known manner. TheRFID tag 698 can comprise any suitable tag known in the art. As notedabove, in some embodiments, the light seal 690 can comprise adisposable, removable, and/or replaceable layer that is positioned on anexternal portion of the light seal 690 (e.g., on a surface of the lightseal that comes in contact with the subject's face/eye). The RFID tag698 can be incorporated in the disposable layer of the light seal 690 toensure that the disposable layer 692 is an authentic disposable and alsoto enforce single usage of the disposable layer.

As detailed above, any suitable technique can be employed for operatingon the detected signals and arriving at a degree of alignment of thelight source relative to the subject's pupil. Further, upon thedetection of a misalignment of the light source relative to thesubject's pupil, the controller 610 can cause the movement of themovable platforms 603, 603′ via a feedback loop to bring the lightsource S and/or the optical components O, in substantial alignmentrelative to the subject's pupil. More specifically, in some embodiments,the controller 610 can actuate various means (e.g., motors) for movingthe movable platform along X, Y and Z directions.

Further, during the performance of an ophthalmic test, the alignmentmechanism 605 can continuously track the position of the subject's pupiland continuously correct for any misalignment of the light sourcesrelative to the subject's pupil. In this manner, the alignment mechanismcan correct, for example, for involuntary movements of the subject'seye, vibrations and other unwanted motions of the optical system, amongothers.

In some embodiments, the pupil(s) of the subject's eye(s) can be dilatedprior to using the system 600. The automated pupil tracking mechanism605 can be configured to correct for the subject's pupil size and forany changes induced in the subject's pupil(s). The automated pupiltracking mechanism 605 can provide the corrections in real time.Alternatively or additionally, the pupil tracking mechanism 605 can beconfigured to correct for the position of the subject's upper and/orlower eye lids and/or eyelashes in correcting for and determining thesubject's pupil size or position. Further, in correcting for thesubject's pupil size, the system 600 can adjust the intensity of thestimulus and/or the bleaching lights applied to the subject's eye. Inother words, the system 600 can adjust the intensity of the stimulusand/or bleaching lights applied to the subject's eye based on the sizeof that subject's pupil(s).

The ophthalmic testing system 600 can also include a feedback system608. The feedback system 608 can be coupled to the pupil trackingmechanism 605 (e.g., the infrared light source IR_(S) and the infraredlight detector IR_(D)) and/or the one or more mechanisms 601 forcontrolling the light source S and/or the optical system O. The feedbacksystem 608 can be configured to detect the position of the pupil of thesubject's eye 691 based on the signals generated by the infrared lightdetector IR_(D) and/or receive the position of the pupil of thesubject's eye 691 from the automated pupil tracking mechanism 605. Thefeedback system 608 can use the position of the pupil of the subject'seye 691 to cause the movement of the light source S and/or the opticalsystem O through the mechanism 605 (e.g., using the platform 603, 603′)and direct and align the light emitted by the light source S at thepupil of the subject's eye 691.

For example, the feedback mechanism 608 can align the light emitted bythe light source S based on a shape of the subject's pupil in an imagegenerated by an infrared camera of the infrared light detector IR_(D).Specifically, the infrared light source IRs can include two or more spotlight sources or an aperture configured to produce a known shape todirect toward the subject's eye. The reflection of the infrared lightsource IRs as captured by the infrared light detector IRD can be used tomeasure the distance between two or more infrared spot reflections ormeasure the size of an infrared shape reflection at the subject's eye.The measured dimension of the reflected infrared feature within thecaptured image can be used to determine the Z-position (horizontalposition) of the eye as a distance away from the infrared light detectorIR_(S), and thus calculable the distance away from the optical system O.

Further, the measurements of infrared spot light reflections and/orinfrared features can be used to self-calibrate the system, determinethe subject's eye Z-position (horizontal position), and properlydetermine the subject's pupil size. Given that each subject can have herown unique facial features/dimensional anatomical features (i.e., eyeposition relative to the subject's head), by calibrating the system foreach subject, embodiments disclosed herein can achieve more accuracy.Furthermore, as noted above, the feedback mechanism 608 can adjust theintensity of the test light source based on the size of the pupil of thesubject's eyes.

As noted above, the system 600 can further comprise a light seal 690configured to isolate at least one eye (e.g., the test eye 691) of thesubject from ambient light. The light seal 690 can comprise one or moreportions and/or elements, each of which can be reusable and/ordisposable. For example, the light seal 690 can comprise one or more eyecups that are configured to surround the area around at least one eye ofthe test subject and seal the at least one eye from ambient light. Theone or more eye cups can comprise any suitable material known in the artand can be reusable (can be used with multiple test subjects, does notneed to be changed every time a new subject is tested, and/or can becleaned before/after each use) and/or disposable. The light seal 690 canbe attached to the frame 602 using any suitable means. For example, thelight seal 690 can be inserted within a receptacle provided in theframe, glued to the frame, or attached to the frame using other suitablemeans of coupling.

Further, the light seal 690 can be configured such that it can isolateone or both eyes of the subject from ambient light. The light seal 690can also be configured such that it can independently isolate each eyeof the subject from ambient light (e.g., can provide a different,separate, or independent light seal for each eye). Generally, the lightseal 690 can be configured according to any suitable technique and/orusing any suitable materials available in the art informed by thepresent teachings. For example, the light seal 690 can comprise aconformable material (e.g., silicone) and/or be configured such that itis substantially conformable to at least a portion of the subject'shead. Alternatively or additionally, the seal 690 can comprise aconformable body having at least one opening 690o configured to besubstantially aligned with at least one eye 691 of the subject when theframe 602 is worn by the subject. The conformable body can be coupled tothe frame 602 such that the combination of the frame 602 and the lightseal 690 can isolate the eye 691 of the subject from ambient light whenworn by the subject and/or placed adjacent to the subject's face orhead.

The light seal 690 can include any suitable mechanism available in theart for adjusting the light seal around the subject's eye 691 and/or forattaching the conformable body of the seal 690 removably and replaceablyaround the subject's head. For example, the light seal 690 can include aratchet 692, which can be mounted on the frame 602 and coupled to thelight seal 690, and configured to adjust the light seal 690 around thesubject's eye/head 691. Such isolation of the subject's eye(s) from theambient light can be important in measurements of dark adaptation andalso in performing various other ophthalmic tests and measurements, suchas detection of vitamin A deficiency, Sorsby's Fundus Dystrophy, lateautosomal dominant retinal degeneration, retinal impairment related todiabetes, diabetic retinopathy, drug induced retinal toxicity, glaucoma,ocular hypertension, retinal hypoxia, retinitis pigmentosa, and fundusalbipunctatus.

Additionally or alternatively, an attachment mechanism 694 canmechanically couple the ratchet 692 to the light seal 690. Theattachment mechanism 694 can be a strap that is configured such that itcan be used to adjust at least one of a length and tension in the strap694, and thereby adjust the light seal around the subject's eye 691.Additionally or alternatively, the attachment mechanism 694 can compriseat least one arm coupled to the conformable body of the seal 690.Further, an additional strap 694′ can be coupled to the frame 602 of thesystem 600 and configured to adjust attachment of the frame 602 to thesubject's head. A quick release button 686, 687 can be coupled to atleast one of the straps 694, 694′ to allow facile release of the straps694, 694′. The straps 694, 694′ can comprise any material known in theart, for example an elastic material.

It should be noted that, although shown as being separate from the frame602, the one or more portions of the light seal 690 can be directlycoupled to the frame 602 of the system 600, be removably coupled to theframe 602 of the ophthalmic testing system 600, be fixedly coupled tothe frame 602 of the ophthalmic testing system 600, and/or be anintegral part of the frame 602 of the ophthalmic testing system 600.Further, it should be noted that in order to ensure hygienic usage ofthe system, various portions of the system 600 that are expected to comein contact with the test subject's skin, body, hair, face, and/or eyecan be lined with a removable, replaceable, and/or disposable layerand/or any suitable material that can be cleaned (e.g., using a medicalgrade cleaner) before/after use.

The system 600 can further comprise one or more sensors 693, 693′. Forexample, the system 600 can comprise at least one of: a pressure sensor,a capacitive sensor, and a light sensor. The one or more pressure,capacitive, and light sensors 693, 693′ can be included at any suitablelocation within the system 600 and configured such that they can detectvarious conditions and status of the system. For example, the light seal690 can comprise one or more light sensors 693 configured to detectpassage/leakage of light through the light seal 690.

The system 600 can further comprise one or more pressure sensors 693configured to ensure that appropriate contact between the system 600(e.g., head-wearable device) with the subject's face, head, or eye(s)has been established. The sensors 693 can be disposed at any suitablelocation (on the light seal) within the system 600, for example on theheadset and/or head strap of the head-wearable device.

Additionally or alternatively, the system 600 can include one or moremotion sensors 641, 684 configured to track and/or monitor the motionand/or movement of the system 600 and/or the subject. For example, thesystem 600 can comprise at least one motion sensor 641 (e.g., comprisingat least one of an accelerometer and/or a tilt sensor) that isconfigured to monitor, track, and/or collect information indicatingsudden acceleration or deceleration of the system 600. It should benoted that the term “motion sensor,” as used herein, is intended torefer to any type of sensor available in the art that can monitor,track, or be used to obtain information regarding motion, location,orientation, and/or position of any component of the ophthalmic testingsystem 600.

The information collected by the at least one motion sensor 641 can beused in monitoring the general status of the ophthalmic testing system600. For example, in some embodiments, the system 600 can comprise amotion sensor 641 and/or an inertial measurement sensor (IMS) 693/641that can be used to collect information regarding unexpected changes inthe motion of the device and/or undesired events, such as whether thesystem 600 has been dropped (e.g., if a head-wearable implementation ofthe system has been dropped), whether the system 600 has taken anyundesired impact, whether the system 600 has been transported from itsintended usage facility (practitioners transporting a tabletopimplementation between various facilities and possibly damaging thedevice in the process), etc. The information collected by the sensors693/641 can be forwarded (e.g., via a processor 310 in the digitalcircuitry of the system) to an entity that tracks, records, and/or makesuse of such information. For example, the information regardingunexpected motions of the device can be transmitted to an entity (e.g.,original manufacturer) providing/offering warranties on the device. Inthis way, the system can automate possible responses to insurance andwarranty damage claims made by users because it can track and identifydamages that occurred due to user's own negligence (e.g., caused bydropping the device). Further, to ensure successful tracking of devices,the system can maintain its own backup power/battery source to ensurethat tracking is accomplished even when the testing system is turnedoff.

It should be noted that although described with reference to motion andinertial measurement sensors, the ophthalmic testing system 600 cancomprise any means for detecting occurrence of unexpected/undesiredevents in the ophthalmic testing system 600. For example, the ophthalmictesting system 600 can comprise at least one of a motion sensor, atemperature sensor, a humidity sensor, microphone, global positioningsystem (GPS), gyroscope, light sensor, infrared sensor, proximitysensor, system clock, and/or an accelerometer. The undesired events canalso include any event that can be of interest to an authorized party(e.g., original manufacturer). For example, the undesired events can bean opening of a cover of the ophthalmic testing system. The sensorscould be integrated into a single printed circuit board or dispersedthroughout the testing system on multiple printed circuit boards.

The system 600 can further comprise a subject-instruction system 660configured to provide the subject with instructions for conducting anophthalmic test. The subject-instruction system 660 can allow anauthorized party (e.g., a medical professional) to communicate with asubject during the ophthalmic test or measurement. For example, thesubject-instruction system 660 can be used by a medical professional toprovide instructions and/or feedback to a subject undergoing anophthalmic test or measurement. The subject-instruction system 660 cangenerally utilize the processor 310, and other elements of the digitalcircuitry of the system 600 (e.g., at least one random access memory(RAM), permanent memory, communication interface 340, a speaker 467, andappropriate connections (e.g., bus)) that allow the processor 610 tocommunicate with various components of the system 600, to receiveinstructions from a medical professional, provide responses, and/orrequest for assistance/guidance.

In some embodiments, the subject instructions system 660 can issue oneor more commands for directing the test subject through the testenvironment (e.g., testing room). The one or more commands for guidingthe test subject include at least one of 1) address or location of anexam room in which the ophthalmic test is administered, 2) informationregarding the ophthalmic test, and 3) expected wait time until theophthalmic test is administered.

The system 600 can further comprise a monitoring system 665 formonitoring at least one attribute of at least one eye of the subject(e.g., measurement of dark adaptation). The monitoring system 665 can bein communication with the automated subject-instruction system 660 andconfigured to cause the subject-instruction system 660 to provide one ormore instructions to the subject in response to monitoring of the atleast one attribute of at least one eye of the subject. For example, themonitoring system 665 can utilize the subject-instruction system 660 toprovide instructions to the test subject regarding the attribute(s)being monitored. The monitoring system can provide these instructionsvia the interfaces included in the system 600, for example using audioinstructions provided through the speaker 467/650.

The speaker 650 can be coupled with the monitoring system 665 andsubject-instructions system 660 and configured to provide the subjectwith instructions (audio communication) for monitoring the at least oneattribute. For example, the speaker 650 can be configured to receiveinstructions signals from the monitoring system 665 andsubject-instructions system 660 and convert these signals into audiosignals and provide the subject with audio instructions that direct thetest subject to focus her gaze on the fixation light, instructions thatdirect the test subject to continue responding to the stimulus light,information regarding the amount of time remaining in the test, etc.

Specifically, as detailed below, the monitoring system 665 and thesubject-instruction system 660 (e.g., an automated subject-instructionsystem) can be connected to at least one processor (e.g., processor 310)and configured to send and receive signals to/from the processor. Themonitoring system 665 can monitor various attributes of the test (e.g.,a subject's response to a stimulus) and send information regarding thatattribute (e.g., the subject's response and/or whether the subjectcontinues to provide a response) to the processor. The processor canprocess the information received from the monitoring system 665 anddetermine whether any information should be provided to the subjectand/or the subject should receive instructions as to how to continuewith the remainder of the test (e.g., whether the subject should beinstructed to focus her gaze). Upon determining that certaininstructions should be provided to the subject (e.g., instructions tocontinue to focus gaze, instructions to continue to provide responses),the processor can access at least one random access memory module (RAM)or a permanent memory module (e.g., memory 320) and identify at leastone relevant form of audio file (e.g., in the form of Waveform AudioFile Format) that can be used to provide those instructions to the testsubject (e.g., identify an audio file that includes commands forinstructing the subject to focus her gaze). The processor can obtain theidentified audio files from the memory and cause the execution of thefiles by instructing the speaker 650 to play the audio files for thetest subject. The audio signals can be provided in the form of naturallanguage/verbal commands.

Additionally or alternatively, the automated subject-instruction system660 and/or the monitoring system 665 can be coupled to a display 670 andconfigured to display the relevant information and instructions (e.g.,subject instructions) for use by the provider (e.g., technician)conducting the ophthalmic testing and measurement. For example, thedisplay 670 can provide the technician with comments (focus your gaze)and prompt the subject to provide the instructions (e.g., reading outthe instructions) to the test subject.

Further, the system 600 can comprise an alert mechanism 630 that canprovide an alert signal to the subject and/or the practitioner inresponse to the information provided by the monitoring system 665 and/orthe resulting instructions provided by the automated subject-instructionsystem 660. The alert mechanism 630 can further be configured such thatit monitors the one or more sensors 693, 693′ and in an event airregularity or an undesired condition in the contact between the lightseal 690 and the subject's face, head, or eye(s) is observed, generatean alert that notifies an operator of the detected conditions. Forexample, in some embodiments, the monitoring system 665 can monitor theinformation received from the sensors 693/641 to determine if there isleakage of light through the light seal 690 (based on informationreceived from a sensor monitoring the light seal) and/or if the subjecthas moved (based on information received from inertial and/or motionsensors) and upon observing such conditions alert the practitionerand/or the subject of these conditions. The alert mechanism 630 canprovide the alert signals to the subject and/or clinician via anysuitable interface, for example by providing audio signals (e.g., verbalsignals) via the speaker 650 and/or visual signals via the display 670.

Moreover, the alert mechanism 630 can be configured to generate an alertin an event a light sensor 693, 693′ detects a possible light leakagethrough the light seal 690. For example, the alert mechanism can beconfigured to generate an alert in an event passage of light having anintensity greater than 0.005 Scotopic Cd/m² is detected in the lightseal 690. The alert system/alert mechanism 630 can further be configuredto identify the eye of the subject, in vicinity of which the lightleakage is detected. For example, the alert system 630 can be configuredto generate an audio alert in response to the detection of the lightleakage.

Alternatively or additionally, the alert mechanism 630 can be configuredto inform an individual administering the ophthalmic testing andmeasurement using the system 600 that the ophthalmic testing andmeasurement is complete. For example, as shown in FIG. 4C, in oneembodiment, the alert mechanism 630 can be configured to inform anindividual administering a Rod Intercept™ (RI™) test for measurement ofdark adaptation using the system 600 that the test is complete and/or ifa malfunction has occurred. As shown, the alert mechanism 630 can informthe individual administering the dark adaptation test by generatingand/or issuing an alarm signal (e.g., a visual signal as shown in FIG.4C). The alarm signal can indicate to the individual that the test hasbeen completed and/or that a malfunction (e.g., fixation error) hasoccurred.

As noted with reference to FIG. 4A, the system 600 can comprise a userinterface (subject-response interface) 680 configured for use by thesubject to provide the system 600 with feedback in response to theophthalmic test or measurement being conducted. The subject-responseinterface 680 can comprise any suitable interface available in the art.For example, the subject-response interface 680 can be a touch sensitivebutton, a push button, a five-way rocker button, and/or a traditionalcomputer mouse. The subject-response interface can be coupled with aresponse analyzer 185 that is configured to analyze and assess thesubject's response/feedback received through the subject-responseinterface 680. For example, in one embodiment, the response analyzer 185can be configured to analyze the feedback of the subject for assessingdark adaptation of at least one eye of the subject. The analyzer caninclude a processor (e.g., processor 310) and a memory (e.g., memory620) coupled with the processor and configured to store instructions foranalyzing the response of the subject (e.g., response to a stimuluslight in analyzing dark adaptation).

Further, as also noted with reference to FIG. 4A, the ophthalmic testingand measurement system 600 can further include a provider interface 611that can be directly included in the frame 602, coupled to the frame602, and/or positioned remotely from the frame 602 of the system 600.The provider interface 611 can be configured to be used by a clinicianor technician to provide data (e.g., adjustment data) or testinterpretation and outcome and/or collect and report information (e.g.,test results).

Further, the provider interface 611 can be configured to communicatewith an electronic health record (EHR) or practice management system(e.g., to provide structured file data thereto). Such structured filedata can be stored in a shared folder that can be accessed by multipleentities. The communication center 610 can employ encryption for suchcommunication.

In some embodiments, the system 600 can also comprise a command center666 that is configured to control functions of the system 600, such asinitiating an ophthalmic test, terminating an on-going ophthalmic test,provide verbal and/or visual commands to one or more subjects wearingthe head-wearable devices, etc. In some implementations, the commandcenter 666 can be a mobile device and/or implemented in a mobile device,e.g., an ipad®, and iphone®, or similar devices. In some embodiments,the command center 666 can be positioned remotely from the frame 602 ofthe system 600 and configured to communicate with the system 600 usingany suitable communication protocol including wireless communicationsprotocols, such as Bluetooth, Wi-Fi, or others.

It should be noted that although described as separate components, thevarious components of the system 600 can be implemented as parts of thesame device or system. For example, as described with reference to FIG.4A, the interface unit 460 can be configured to function as both asubject-response interface and a provider interface and also provide atleast some of the functions provide by the command center 666.

Alternatively or additionally, the system 600 can comprise a call button699, which can be used by subject to communicate with the individualadministering an ophthalmic test (e.g., via sending an alert signal tothat individual). For example, the call button 600 can be configured toallow a test subject to have a dialogue with an individual administeringan ophthalmic test.

Additionally or alternatively, the system 600 can include a powerindicator and/or a power switch 60. The power indicator 60 can becoupled to the 102 and configured such that it can be used to power onand/or power off the system 600 and/or indicate the power status of thesystem 100 (e.g., whether the system is on or off, the amount(percentage) of battery remaining/consumed in, for example, thehead-wearable implementation). It should be noted that the power switch60 can be incorporated in, integrated in, and/or be parts of any otherpart of the system 600.

FIG. 7 is a schematic illustration of a head-wearable device 700according to embodiments disclosed herein. As noted with reference toFIG. 1A, the head-wearable device 700 can comprise one or more lightseals 724R, 724L configured to isolate the optical interface of thehead-wearable device 700 and at least one eye (e.g., a test eye) of thesubject from ambient light. Additionally or alternatively, in someembodiments, the head-wearable device 700 can be configured such that atleast a portion of the headset 202 comprises an opaque region configuredto obstruct passage of ambient light to the subject's eye. For example,as shown in FIG. 7, the head-wearable device 700 can comprise at leastone opaque portion 711. The opaque portion 711 can comprise a materialhaving an adjustable opacity. For example, the opaque portion 711 of thehead-wearable device can comprise a material having an opacity that isadjustable in response to a stimulus.

In some embodiments, the opaque portion 711 can be a liquid crystal thatis configured to transition from translucent to opaque upon applicationof a voltage thereto. Specifically, at least a portion of the opaqueregion 711 can comprise one or more layers of liquid crystal cells 715and one or more layers of a light polarizer 713 (e.g., polarizedfilters) that are configured to achieve a transition between opacity andtranslucence in response to application of one or more voltages thereto.This configuration can provide more comfort to subjects who may havedifficulty with being in a dark environment because it allows the opaqueportion 711 of the head-wearable device 700 to gradually transition frombeing translucent to being fully opaque, thereby providing the testsubject with some time to adjust to the environment (after wearing thehead-wearable device) before the head-wearable device completely blocksthe light passing to the subject's eyes.

The polarized filters 713 can be configured such that they are offset ata predetermined orientation to the underlying filters 215 and areinterlayered with the liquid crystal cell layers. For example, in someembodiments, the polarized filters can be offset at about 90 degreesrelative to the underlying layers. Since the stimulation of the liquidcrystal cells by electricity can change the refraction angle of lightpassing through the liquid crystal cell layers, the polarized filtersand the liquid crystal cell layers can be combined and stacked such thatthey provide a change the opacity of the opaque portions 711 and preventpassage of the light through the opaque portions 711 (or allow the lightto pass through the opaque portions 711).

The opaque portion(s) 711 can be an integral part of the head-wearabledevice 700 and/or be removably or replaceably attached to thehead-wearable device 700. For example, as shown in FIG. 8, at least aportion of the head-wearable device can comprise one or more opaqueportions 811, 811′ that have been hingedly coupled device 700. In someembodiments, the one or more opaque portions 811, 811′ can be coupled tothe front face 817 of the head-wearable device.

The opaque portion 811 can be the head-wearable device using at leastone hinge 814, 814′ and configured such that the opaque portion can belifted to allow passage of ambient light to at least one eye of thesubject. Alternatively or additionally, the opaque portion 811′ cancomprise a slidable screen configured to be slidably positionedsubstantially in front of at least one eye of the subject to obstructpassage of light thereto. The head-wearable device can comprise anysuitable mechanism needed to accommodate coupling of the opaqueportion(s) 811, 811′ to the device. For example, at least a portion ofthe head-wearable device can comprise a rail 825 configured to allow theslidable opaque portion 811′ to slide onto the head-wearable device(front face of the head-wearable device).

In some embodiments, a flip seal 850 can be disposed to an area 890R ofthe front face 817 of the head-wearable device and configured such thatupon placement of the flip seal 850 on the front face of head-wearabledevice, passage of ambient light to the subject's eye(s) is obstructed.Under this configuration, lifting of the flip seal 850 allows passage ofthe light through the area 890R of the face 817 to the subject's eye(s).In other words, the flip seal 850 and/or the opaque portions 811/811′,once placed on the front face of the head-wearable device, areconfigured to be positioned in substantial register with the subject'seye when the head-wearable device is placed against the subject's faceand to block ambient light from entering the subject's eye. Similarly,lifting/sliding the flip seal 850 and/or the opaque portions 811/811′about the hinge 814/814′ and/or on the rail 825 can allow the ambientlight to enter the subject's eyes.

As noted, in a closed configuration, the light-blocking portions 821,821 can inhibit, or at least minimize, the passage of ambient light tothe subject's eye. In an open configuration, the light-blocking portionscan be lifted via rotation about the hinge(s) 814, 814′ to expose thecavities/chambers 889L, 889R to allow the ambient light to reach thesubject's eye(s). This configuration can allow the positioning of thehead-wearable device and mask on the subject's eye, while the subject isstill able to receive ambient light, thereby transitioning the lightluminance from ambient to a much lower level needed for performing theophthalmic test. Such a transition is herein referred to as “going darktransition,” and can help the subject to adapt more readily to the darkcondition required for performing the ophthalmic test.

FIGS. 9A-9E depict various illustrative examples of head-wearableimplementations of an ophthalmic testing and measurement device 900/900′according to some embodiments disclosed herein. FIG. 9F illustrates anexploded view of the example shown in FIG. 9E. FIG. 9G illustrates aperspective view of a light seal according to some embodiments disclosedherein.

The head-wearable device 900/900′ can generally be configured to performany suitable ophthalmic diagnostic procedure on at least one eye of asubject 991. For example, the head-wearable device 900/900′ can be usedin performing an ophthalmic diagnostic test, such as measurement of darkadaptation, in at least one eye of a subject 991.

As shown in FIGS. 9A-9E, and 4C, the headset 902 can include a housingor chamber 902H, in which various components of the ophthalmic testingand measurement device can be disposed. The housing 902H can house theoptical and electronic components (e.g., optical systems, etc.) that arerequired for performing the one or more ophthalmic tests and/ormeasurements that can be conducted using the head-wearable device900/900′. The chamber 902H can include a front face 972, a top face 973,a bottom face (not shown), and a back face 974.

As noted with reference to FIG. 9E, the chamber 902H can include one ormore partitions that are configured to divide the chamber 902H into twoor more compartments, each of which can be associated with one of theeyes of the subject. For example, the chamber 902H can include twocompartments 998R, 998L, each of which can be associated with one of theeyes of the subject. The compartments 998R, 998L can comprise externalcup-shaped features and be configured such that each compartment 998R,998L is adjacent to and/or surrounds at least one eye of the subject(e.g., compartment 998R surrounds the right eye and compartment 998Lsurrounds the left eye).

The interior portions of each compartment 998R, 998L can house variouscomponents and can be configured to perform various functions requiredfor conducting the one or more optical tests and measurements performedby the head-wearable device 900/900′. For example, compartments 998R,998L can house the components required for conducting the same testand/or measurement. Specifically, the compartments 998R, 998L can beconfigured such that they house the components required for conducting atest or measurement (e.g., measurement of dark adaptation) on one eye orboth eyes of the subject. For example, in embodiments that utilizeremovable cartridges (e.g., cartridges 500R, 500L in implementationshown in FIG. 5A) the compartments 998R, 998L can be configured to housethe removable and replaceable cartridges.

Alternatively or additionally, the compartments 998R, 998L can beconfigured to house the components required for conducting differentophthalmic tests and/or measurements. For example, the compartments998R, 998L can be configured such that one compartment houses thecomponents required for conducting a first ophthalmic test and/ormeasurement on one eye of the subject while the other compartment housesthe components required for conducting a second ophthalmic test and/ormeasurement on the other eye of the subject. As noted above, thesecomponents can be removable and replaceable and/or be an integral partof the ophthalmic system. Alternatively or additionally, at least onecompartment 998R, 998L can be at least partially empty. Further, in someembodiments, at least one compartment 998R, 998L can be at leastpartially sealed to block ambient light from entering the compartmentthat houses the components required for conducting the ophthalmic testand/or measurement being provided by the head-wearable device 900/900′.

As noted above, the head-wearable implementations 900/900′ of thetesting and measurement systems described herein can include ahead-wearable headset 902 that can be worn by the subject and/or mountedon the subject's head such that at least a portion of the device isadjacent to at least one eye of the subject. The headset 902 can bemounted on the subject's head using any available and suitablemechanism. For example, as noted above, a strap 994 can be coupled tothe headset 902 and configured to allow the subject to wear thehead-wearable device 900/900′ such that the head-wearable headset 902 ispositioned against at least a portion of the subject's head when worn bythe subject 991. The strap 994 can be adjustable to ensure that it canbe adjusted to fit around each individual subject's head and provide acomfortable fit for each individual subject.

Generally, the strap 994 can be connected to the headset 902 using anysuitable or available mechanism. For example, the strap 994 can berotatably coupled to the headset 902 using one or more adjustablemechanism 935. Alternatively or additionally, the strap 394 can becoupled to the headset 902 using one or more rotatable dials, hinges,and/or ratchets 935. The one or more rotatable dials, hinges, and/orratchets 935 can be configured such that they allow the strap 994 torotate to any desired or suitable orientation or dimension.

For example, the strap 994 can be coupled to the headset 902 using aresistive hinge 935 that is configured such that they can provide thestrap 994 with from about 5° to about 225° degree of rotation relativeto the headset 902. This rotatable feature of the strap 994 can allowthe strap 994 to be comfortably fitted to a subject's head. Further, theadjustable mechanism 935 can incorporate a dampener that providesresistance to rotation. Specifically, the dampener can be configured toprevent unwanted rotation of the strap 994 such that the adjustablemechanism 935 requires physical manipulation of the strap 994 andheadset 902 to reposition these elements relative to one another.

The strap 994 can comprise one or more layers of materials. For example,the strap 994 can include an internal layer 934 on the side of the strapthat is configured to come in contact with the subject's head. Further,the internal layer 934 can be removably and replaceably coupled to thestrap 394. For example, the internal layer 934 can comprise a disposablelayer that is configured to be disposed and/or replaced after each use(or after a number of uses). In some embodiments, the disposable layer934 can comprise an adhesive (e.g., Velcro®) that allows for attachmentand/or removal of the disposable layer from the strap 994.

Alternatively or additionally, at least one of the strap 994 and theinternal layer 934 can comprise a material that allows for surfacecleaning of the internal layer 934 and/or the strap 994 before/aftereach use. For example, at least one of the internal layer 934 and thestrap 994 can comprise woven or non-woven natural or polymeric fiber, amaterial (e.g., metal such as aluminum, stainless steel, copper, etc. orpolymer such as Delrin, polycarbonate, polyurethane, etc.) that iscapable of being cleaned with traditional medical grade cleaning agents(e.g., rubbing alcohol), etc.

The strap 994 can also include at least one adjustment dial 935 that canbe used to adjust the length of the strap 994 and provide a suitable andcomfortable fit for the subject's head. The adjustment dial 935 can beconfigured such that it can be used to adjust the head-wearable device900/900′ around the subject's head to any suitable orientation, length,and/or position. Further, the adjustment dial 935 can be configured suchthat it can be manually and/or automatically (e.g., under instructionsreceived from a processor 310 (shown FIG. 3)) adjusted to provide asuitable and/or comfortable fit around the subject's head.

The head-wearable device 900/900′ can also include a light seal 990configured to isolate at least one eye of the subject from ambientlight. As noted above, the light seal 990 can be coupled to the headset902 and configured to isolate at least one eye of the subject (e.g., insome embodiments both eyes of the subject) from ambient light.

The light seal 990 can be an integral part of the device 900/900′ and/orbe removably or replaceably coupled to the headset 90 of thehead-wearable device 900. Further, the light seal 990 can generallycomprise any suitable material known in the art. For example, the lightseal 990 can comprise a polymeric material, such as at least one ofsilicone, polyurethane, neoprene, polyolefin, nitrile rubber, ethylenevinyl acetate (EVA), polyvinyl alcohol (PVA), and polylactic acid (PLA).Additionally or alternatively, the light seal 990 can comprise aplurality of fibers, such as cellulose fibers and/or a foamed material,such as any of closed-cell or open-cell polymeric foam, alginate foamand starch-based foam.

The light seal 990 can have various features that are configured tofacilitate formation of a light seal around at least one of thesubject's eyes. For example, the light seal 990 can include one or moreflanges 995R, 995L that are configured to conform to the areassurrounding the subject's eyes and/or at least a portion of thesubject's head in order to form a seal that inhibits, and preferably,prevents the ambient light from entering the subject's eye(s). Theflange 995L, 995R can comprise any suitable available material and beformed to assume any suitable shape and/or size.

As noted, the light seal 990 can be configured to isolate each eyeindependently from ambient light or isolate both eyes simultaneouslyfrom the ambient light. For example, the light seal 990 can beconfigured to ensure independent isolation of each of the subject's eyesfrom the ambient light.

In some embodiments, the light seal 990 can include two cup-likeportions 998R, 998L, separated from one another by a common segment R inthe form of a ridge (FIG. 9E). Each cup-like portion 998R, 998L cancomprise a viewing window 997R, 997L that can be configured to allowpassage of the light to at least one eye of the subject. Each cup-likeportion 998R, 998L can be configured such that it snugly surrounds acorresponding eye of the subject to isolate that eye from ambient light.For example, one or more flanges 995R, 995L can surround the areasadjacent to the eyes of the subject on the subject's head, at least aportion of the subject's nose, and/or any area immediately surroundingthe subject's head to isolate each eye from the ambient lightindependently of the other eye. The light seal, including the disposableliner, can be formed using a variety of different materials (e.g.,polymeric materials) and can be disposable or reusable.

In some embodiments, the light seal can comprise a polymeric material.The polymeric material can comprise any of silicone, polyurethane,neoprene, polyolefin, nitrile rubber, ethylene vinyl acetate (EVA),polyvinyl alcohol (PVA), polylactic acid (PLA). Additionally oralternatively, the light seal can comprise a plurality of fibers. Forexample, the fibers can comprise cellulose fibers. Additionally oralternatively, the light seal can comprise a foamed material. The foamedmaterial can comprise any of alginate foam and starch-based foam.

As noted, the light seal 990 can comprise one or more portions, each ofwhich can be reusable and/or disposable. FIG. 9E depicts an illustrativeexample of a head-wearable ophthalmic testing and measurement device900′ having a light seal 990 with at least one disposable portion 912.The disposable portion 912 can be a hygienic liner 912 disposed on thesurface of the conformable body 996 of the light seal 990 and configuredto come in contact with the subject's face/skin when the head-wearabledevice 900/900′ is worn by the subject and/or when the head-wearabledevice 900′ is placed against the subject's face. The hygienic linger912 can be configured such that it comes in contact with the subject'sskin and can be used and/replaced after it comes in contact with asubject's skin. The hygienic liner 912 can be a single-use anddisposable item. In some embodiments, the hygienic liner can comprise adouble-sided tape (e.g., for facilitating attachment/removal of theliner 912 to/from the strap 993).

In some embodiments, a tracking system 998 (e.g., an RFID tag or abarcode, hereinafter referenced generally as “RFID tag”) can beincorporated in the light seal 990. The RFID tag 998 can be coupled tothe light seal 990 and/or the liner 912 in any suitable known manner. Asdescribed with reference to FIG. 1G, the RFID tag 998 can beincorporated in the disposable layer 912 to ensure that the disposablelayer 492 is an authentic disposable (provided by the originalmanufacturer of the device) and also to enforce single usage of thedisposable layer.

In some embodiments, the receptacles or chambers can provide a cavityinto which a light mask according to the present teachings can bepartially fitted. For example, as shown in FIG. 9F-9G, a portion 991 ofthe light mask 990 can be fitted into the receptacles or chambers 989Lto facilitate positioning of the light mask over the subject's eyes.Specifically, the mask 990 can be coupled to the cavity 989L such thatthe openings in the mask 9900 is in substantial register with the windowprovided in the cavity 997R/997L. Under this configuration, when thelight-blocking portions 811, 811′ are closed (e.g., FIG. 8), the subjectcan view the light emanating from the light source(s) of the ophthalmictesting system that is/are positioned in the head-wearable device 900′.The light sources can be disposed in an upper portion 902U of thehead-wearable device 900′. Further, the upper portion 902U of thehead-wearable device 900′ can include other components, such aselectronic components, required for performing an ophthalmic test.

FIG. 10A depicts a block diagram of a light seal 1090 according to someembodiments disclosed herein. As shown, the light seal 1090 can comprisean internal cavity 1099 having one or more cups 1098R, 1098L, eachconfigured to seal one eye of the subject from ambient light. In theexample shown in FIG. 10A, the left cup 1098L can be configured to sealthe left eye of the subject from ambient light and the right cup 1098Rcan be configured to seal the right eye of the subject from ambientlight. Although shown as connected units, the light seals 1098R, 1098Lneed not to be connected and can be independent elements (for example,as shown in FIG. 1F). Further, a light seal can be configured such thatit can seal either eye (right or left) of the test subject and/or iscapable of being coupled to either eye interface (right or left) of ahead-wearable implementation.

The light seal 1090 can further include one or more viewing windows thatare configured to allow passage of light to at least one eye of thesubject. In the example shown in FIG. 10A, light seal includes a viewingwindow 1097L, 1097R in each cup 1098L, 1098R configured to allow passageof light to the respective eye of the subject.

The light seal 1090 can further comprise one or more light sensors 1093a, 1093 b, 1093 c, 1093 d configured to detect an intrusion or leakageof extraneous or ambient light to the subject's eye(s). The lightsensors can be positioned in any suitable manner on the light seal, forexample adjacent to the viewing windows 1093 c (adjacent to viewingwindow 1097L), 1093d (adjacent to viewing window 1097R), and beconfigured to detect possible leakage or intrusion of light into thecavity 1099 of the light seal 1090.

Alternatively or additionally, the light seal 1090 can include one ormore light sensors 1093 a, 1093 b positioned on any suitable locationwithin the cavity 1099 of the light seal 1090. For example, the lightseal 1090 can include one or more sensors 1093 a, 1093 b on theboundaries of the seal 1090 (e.g., where the seal 1090 comes in contactwith the subject's face or skin). The light sensors 1093 a, 1093 b, 1093c, 1093 d can comprise any suitable light sensors. For example, thelight sensors 1093 a, 1093 b, 1093 c, 1093 d can comprise one or morephotodiodes (e.g., avalanche photodiodes) configured to sense anyintrusion of extraneous light. In some embodiments, the one or morephotodiodes can be located in the chamber 1099, inclusive of the anyinternal volumes of the assembly including on or near the optics, oninterior of the eyecup, on or near disposable portions of the lightseal, on the inside of the headset, and/or within the optics channelchamber.

The light seal 1090 can further comprise at least one of a pressuresensor and/or a capacitive sensor 1093 p. The one or more pressuresensors can be included at any suitable location on the light seal 1090.Such pressure sensors can include, but are not limited to, one or morestrain gauges disposed at key points along the elastomeric eyecups1098L, 1098R and/or on the light seal 1090 to ensure an adequate sealingforce is applied.

In some embodiments, the elastomeric eyecup 1098L, 1098R material can beimpregnated with a conductive filler (e.g., carbon black) capable ofassessing compressive force via change in electrical resistance orelectrical capacitance in the eyecup. In such embodiments, sensors 1093g capable of measuring such changes (e.g., capacitive sensors) can beused to ensure an adequate sealing force is applied at all points aroundthe perimeter of the eyecups 1098L, 1098R.

For example, as shown in FIG. 10B, the capacitive sensor 1093 g cancomprise at least two plates 1093 g-1, 1093 g-2, disposed on the lightseal 1090. By way of example, the capacitive sensor 1093 g can comprisetwo plates 1093 g-1, 1093 g-2, disposed on opposite sides of the lightseal 1090 (e.g., inner side of the light seal and outer side of thelight seal). The pressure exerted on the light seal 1090 during use (orreduction of pressure to the light seal) can cause the light seal todeform, thereby reducing (or increasing) plate separation between thetwo plates 1093 g-1, 1093 g-2. The reduction of plate separation (or anincrease in plate separation) can, in turn, result in an increase (ordecrease) in the capacitance of the capacitive sensor, therebyactivating the sensor 1093g. The optical system can be configured suchthat if the capacitance detected by the sensor 1093 g falls above orbelow a predetermined range, it triggers an alarm (e.g., using the alertsystem 630) indicating a possible leakage of light through the lightseal 1090.

Alternatively or additionally, a disposable light seal 1090incorporating a polymeric material impregnated with a conductive filler(e.g., carbon black) capable of assessing compressive force via a changein electrical resistance can be used to ensure an adequate sealing forceis applied at all points around the perimeter of the eyecups 1098L,1098R and/or disposable light seal 1090. Any other sensors, for examplesensors (e.g., mechanical switch, magnet and Hall effect sensor, LEDlight switch, ultrasound sensor, etc.) capable of sensing a distanceand/or proximity of the headset to at least a portion of the subject'seye can be employed in accordance with embodiments disclosed herein.

As noted above, a processor (e.g., processor 310 of an ophthalmictesting system according to embodiments disclosed herein) can be coupledto the sensors and configured to receive and process the informationobtained by the sensor(s) included in the light seal 1090. In response,the processor 310 can trigger an alarm signal and/or provide anotification (e.g., via audio or visual notification) alerting apractitioner and/or the test subject of possible leakage of lightthrough the light seal 1090.

FIG. 11 depicts an illustrative example of an optical chamber 1110 inwhich the optical components (sources and optics) of the head-wearabledevice can be stored. The optical chamber 1110 can comprise one or morecompartments. For example, the chamber 1110 can be divided into fourcompartments 1111, 1112, 1113, 1114. Further, each compartment of thechamber 1110 can be arranged to include one or more light sources and oroptical elements. The one or more light sources can be configured togenerate and/or deliver light at one or more luminance levels. Forexample, at least one light source can be configured to deliver a lightat a first luminance level capable of bleaching photopigments and/ordesensitizing a portion of the rhodopsin molecules in a test eye of asubject (the eye of the subject that is undergoing ophthalmic testingand/or measurement). A light source having such capabilities isgenerally referenced herein as a bleaching light source and light raysilluminated at such illuminance levels are generally referenced hereinas a bleaching light. At least another light source can be configured todeliver a light at a second luminance level capable of isolating theresponse of the rod-shaped cells and stimulating the rod-shaped cellswith no or little stimulation of the cone-shaped cells. A light sourcehaving such capabilities is generally referenced herein as a stimuluslight source and light rays illuminated at such illuminance levels aregenerally referenced herein as a stimulus light. At least one otherlight source can be configured to deliver a light at an illuminancelevel configured for use for focusing the test eye of the subject. Alight source having such capabilities is generally referenced herein asa fixation light source and light rays illuminated at such illuminancelevels are generally referenced herein as a fixation light.

The one or more light sources can be used to provide a bleachingprotocol to the individual undergoing visual testing. The bleachingprotocol can be varied as needed according to any suitable and availabletechnique. For example, the bleaching protocol can be configured toexpose the test eye of the subject to a bleaching light. As noted above,the bleaching light is configured to desensitize at least a portion ofthe rhodopsin molecules in the test eye on exposure to the bleachinglight. Visual recovery (e.g., dark adaptation) is then measured via thestimulus light. Accordingly, the bleaching light is configured to serveas a standardized baseline from which visual recovery can be measured.

Generally, any bleaching protocol that can provide a standardizedbaseline can be used with the embodiments described herein. Thebleaching light is generally configured to be brighter than the stimuluslight and the absolute intensity values of the bleaching light andstimulus light can be varied as desired. Generally, bleaching lightshaving higher intensity levels (larger absolute value of the intensitylevel) require shorter exposure time periods to achieve the baselinerequired for measuring dark adaptation. In some embodiments, theintensity of the bleaching light can be, for example in a range of about1.5 log Scotopic Trolands/sec to about 8 log Scotopic Trolands/secand/or an intensity in a range of about 3 log Scotopic Trolands/sec toabout 5 log Scotopic Trolands/sec.

As noted above, the bleaching protocol can desensitize a desired amountof rhodopsin molecules and provide a standardized baseline to measurevisual recovery to the stimulus light. The intensity of the bleachinglight or the time of exposure to the bleaching light can be modulated toproduce the desired amount of desensitization. For example, anequivalent of about 50% to 100% of the rhodopsin molecules can bedesensitized. The intensity of the bleaching light can also be adjustedto desensitize the appropriate amount of rhodopsin molecules. Forexample, a bleaching light intensity of 7.65 log Scotopic Trolands/seccan be used to bleach approximately 98% of the rhodopsin molecules,while a bleaching light intensity of 5.36 log Scotopic Trolands/sec canbe used to bleach approximately 50% of the rhodopsin molecules, while ableaching light intensity of 1.56 log Scotopic Trolands/sec can be usedto bleach approximately 20% of the rhodopsin molecules. If desired,alternate bleaching light intensities which desensitize less than 50% ormore than 50% of the rhodopsin molecules can also be used.

Generally, the bleaching light can comprise one or more wavelengths in arange of about 490 nm to about 510 nm. In some embodiments, thebleaching light can comprise no wavelength component outside the rangeof about 490 nm to about 510 nm. Alternatively or additionally, thebleaching light can comprise one or more wavelengths in a range of about600 nm to about 700 nm. In some embodiments, the bleaching light cancomprise no wavelength component outside the range of about 490 nm toabout 510 nm. Further, the light source emitting the bleaching light canbe configured to generate bleaching light pulses having a duration in arange of about 0.5 milliseconds to about 200 milliseconds. Furthermore,the bleaching light can comprise an intensity in a range of about 1.5log Scotopic Trolands/sec to about 8 log Scotopic Trolands/sec.

After the bleaching protocol is executed, visual recovery can bemonitored and measured via the stimulus light. This recovery of lightsensitivity can be mediated primarily by the retina and can measurepredominately rod-mediated sensitivity. The subject can be asked toprovide a series of responses to the stimulus light, which can be variedin intensity according to one or more index factors. These index factorscan be used to determine a dark adaptation status of the subject.Additionally or alternatively, the response of the subject can be usedto determine a threshold measurement, wherein the threshold can bedefined using the stimulus light intensity at which the subject reportsthe stimulus light as being visible. The threshold can generally bedefined using any suitable technique. One example of thresholdmeasurement is described in detail in U.S. application Ser. No.13/028,893, the entire teachings of which are incorporated herein byreference.

Referring back to the example shown in FIG. 11, the device can compriseone or more fixation light source S₁ ^(F), S₂ ^(F), a bleaching lightsource S₁ ^(B), and a stimulus light source S₁ ^(S). The bleaching lightsource S₁ ^(B) can be adjusted to provide a bleaching light at anysuitable intensity (e.g., high or low intensity light). Further, thebleaching light can comprise an intensity in a range of about 1.5 logScotopic Trolands/sec to about 8 log Scotopic Trolands/sec.

The fixation light source, the bleaching light source S₁ ^(B), and thestimulus light source can generally comprise any suitable light sourceavailable in the art. For example, these light sources can be laserand/or an LED light sources. In one embodiment, the bleaching lightsource S₁ ^(B) can be an achromatic camera flash or a bank of LEDlights. Further, although described as separate light sources, oneskilled in the art should appreciate that a single light source can beused, in some embodiments, to generate one or more of the illuminationlevels employed herein. Further, although the bleaching light source isdescribed as an internal component of the head-wearable device, in someembodiments, the bleaching light source can be omitted from thehead-wearable device, and the bleaching can be carried out independentlyof the head-wearable device.

As noted above, the bleaching light source S₁ ^(B) can generallycomprise any light source capable of emitting a light beam having adesired spectrum for bleaching the photopigments in the test eye. Forexample, the bleaching light source S₁ ^(B) can comprise one or moreLEDs (bank of LEDs) that are configured to emit a light beam 403 (e.g.,white light beam).

Similarly, the stimulus light source S₁ ^(S) can comprise a spectrumeffective in stimulating the rod-shaped photoreceptors of a subject'seye. For example, the stimulus light can comprise one or morewavelengths in a range of about 400 nm to about 750 nm. Alternatively oradditionally, the stimulus light source S₁ ^(S) can be configured togenerate light stimuli having a duration in a range of about 100milliseconds to about 400 milliseconds. In some embodiments, thestimulus light can comprise an intensity in a range of about 5×10⁻⁴cd/m² to about 5 cd/m2. In one embodiment, the initial target stimulusintensity can be 4.85 cd/m2, although other initial intensities can beused. In some embodiments, the stimulus light can comprise an intensityin a range of about 4.0×10⁻⁵ cd/m² to about 5 cd/m².

As noted previously, with reference to FIG. 6, a pair of mirrors can bepositioned at an angle relative to one another and configured to directthe light emitted by the light sources to the subject's eye. The opticscan also include one or more lenses that direct the light to thesubject's eyes. For example, as noted above, a convergent lens can bemounted onto the movable platform 603, 603′, and positioned in the pathof the light in front of the subject's eye for collimating the lightreflected by the mirror(s) before its entry into the subject's eyethrough the pupil. The bleaching light source S₁ ^(B) can generatevisible light (e.g., light having a wavelength in a range of 50 nm to560 nm) at a desired light intensity (e.g., 3 log scotopic Tds to 7 logscotopic Tds). The stimulus light source S₁ ^(S) can generate visiblelight (e.g., 45 nm to 560 nm) and at a desired light intensity (e.g.,5×10⁻⁴ scoptopic cd/m² to 5 scoptopic cd/m²).

The fixation light sources S₁ ^(F), S₂ ^(F) are configured to direct thesubject's gaze toward the respective bleaching light S₁ ^(B) and thestimulus light S₁ ^(S). The fixation light sources S₁ ^(F), S₂ ^(F) canemit visible light at a wavelength and at a desired light intensitythough other wavelengths and light intensities can also be employed.

During the testing and measurement, an image plane can be presented to atest subject. FIGS. 12-13 illustrate examples of two different imageplanes 1200, 1200′ that can be presented to a test subject. The imageplanes can be used with tabletop and/or a head-wearable implementationsof the ophthalmic testing systems described herein.

As noted above, the image plane 1200 can comprise a fixation dot 1210that is presented to the subject using an implementation of theophthalmic testing system according to embodiments disclosed herein. Thesubject is asked to fixate her gaze during the ophthalmic test (withsome rest periods) on the fixation dot 1210. As the subject continues tofixate her gaze on the fixation dot 1210, a bleach area 1230 ispresented in the image plane 1200. The subject is directed to fixatehis/her gaze on the fixation light and is initially presented with ableach pulse of light using the bleach aperture. After the bleachprocess is complete, the image plane is altered to present a smallerstimulus light area 1220 to the user for the rest of the test.

As shown, the bleach area 1230 can comprise an area (having a length123L) that is configured to be larger than the stimulus area 1220(having a length 1220L) in order to ensure that the stimulus area 820 ispresented within the bleach area 1230 and not on any fringes of thebleach area 1230. The bleach area 1230 and the stimulus area 1220 cancomprise different shapes to facilitate distinguishing between thepresentation of the bleach area 1230 and the stimulus area 1220. Forexample, the bleach aperture 1230 can be square-shaped (having a firstlength 1230L) and the stimulus area 1220 can be circular (with adiameter having a second length 1220L, where the first length is largerthan the second length), thereby allowing the subject to easilydistinguish between the presentations of the bleach light and its aftereffects and the stimulus light. The fixation dot 1210 can also comprisean area (having a length 1210L) that is smaller than the areas of thebleach 1230 and stimulus 1220 areas.

FIG. 13 illustrates the image plane 1300 presented to the subject inanother embodiment (e.g., a head-wearable implementation of theophthalmic testing systems disclosed herein). In the embodiment shown inFIG. 12, the subject's eye remains positioned on the optical axis forall phases of the test. However, in the embodiment shown in FIG. 13(which can be utilized in a head-wearable implementation), the opticscan be positioned along the X-axis and configured such that they can bemoved (via motorized control) along the X-axis.

Specifically, the image plane 1300 can comprise a bleach fixation lightarea 1310, having a first diameter 1310L. The test subject can be askedto focus her gaze on the bleach fixation light area 1310 during thebleaching process. In order to carry out the bleaching process, thebleaching area 1330 (having a first length 1330L) is moved in the imageplane (e.g., along the X-direction 1340) such that a center of thebleaching area 1330 it is aligned with the subject's pupil. Uponcompletion of the bleaching process, the subject is asked to focus hergaze on the stimulus fixation point, which can have a similar diameter1310L as the bleach fixation light area. The bleach region is moved awayfrom the alignment with the subject's pupil (e.g., along the X-direction1340) and the stimulus region 1320 is moved (e.g., along the X-direction1340′) to align the with the center of the stimulus with the subject'spupil.

As noted, the bleach area 1330 and the stimulus area 1320 can comprisedifferent shapes to facilitate distinguishing between the presentationof the bleach area 1330 and the stimulus area 1320. For example, thebleach aperture 1330 can be square-shaped (having a first length 1330L)and the stimulus area 1320 can be circular (with a diameter having asecond length 1320L, where the first length is larger than the secondlength), thereby allowing the subject to easily distinguish between thepresentations of the bleach light and its after effects and the stimuluslight. The fixation dots 1310, 1315 can also comprise an area (having alength 1310L) that is smaller than the areas of the bleach 1330 andstimulus 1320 areas.

In some embodiments, the head-wearable device can be directly centeredon the pupil, in the optical center throughout the test (i.e., theoptical assembly is not shifted as described above). Using thisapproach, the subject can rotate his/her eye to the bleach fixationlight for the bleach phase, and the stimulus fixation light for thestimulus phase. Each of these two test approaches requires appropriatedevice calibration based on the pupil position used for the test.

As noted, the head-wearable device can use motorized optical assembliesto accurately position the pupil and move the optical assembly to centerthe bleach center and the stimulus for the bleach and stimulus portionsof the test, respectively. The range of intra-pupil distance for devicepupil positioning is generally identified as 54 mm to 72 mm. In someembodiments (e.g., table top implementations, a motorized chin rest canbe used to accurately position the pupil at the optical axis. Somevariance of pupil positioning is found throughout the test based on asubject's posture and comfort throughout the test.

The bleach/stimulus lights can be projected directly through the imageplane when the bleach is performed. When the stimulus is performed, aneutral density filter and ground glass diffusor are introduced betweenthe LED and image plane, and the image plane aperture is changed to thestimulus aperture. Hotspots can be eliminated through use of a groundglass diffusor or other suitable diffuser materials known in the artwhen the stimulus is presented, and through defocus of the LED withrespect to the image plane position when the bleach is performed. TheLED used for the bleach/stimulus can include an integrated collimatinglens with a narrow projection range. Corrective lenses can be introducedusing a lens holder to improve the image quality presented to the user.

FIGS. 14A-14B illustrate a high-level cross-sectional view 1400, 1400′of some of the optics that can be used in a head-wearable implementationaccording to some embodiments disclosed herein.

In FIGS. 14A-B, the center of the viewing optic 1401, as observed fromthe top, and a reference plane 1402 are shown. The light sources thatpresent the fixation 1405, bleach 1420, and/or stimulus 1410 lights tothe test subject can be disposed in a housing 1430, which can be anysuitable housing available in the art. In some implementations, thefixation light 1405 can be presented through a diffusor 1406 in order tomake the fixation dot appear with improved image uniformity (e.g., nohot spots). The bleach light 1420 can be projected directly, through anadded collimating lens 1431, and through the image plane 1440, when thebleach is performed. The stimulus light can be presented through aneutral density filter 1411 and diffusor 1412 before exiting the imageplane 1440.

Hotspots can be eliminated through use of the diffusor(s) 1406, 1412 forthe fixation and stimulus lights, and through defocus of the lightthrough positioning of the collimating lens 1431 with respect to theimage plane 1440 position when the bleach is performed. The light sourceused for the bleach can include a wide-beam integrated lens. Thecollimating lens can be introduced after the bleach light to provide anarrow projection range. As noted above, in some embodiments, a useradjustment knob/dial can be provided in the headset to adjust the imageplane distance and subjectively improve the image quality presented tothe user. The knob adjusts the distance between image plane 1440 and theviewing optic 1460 to perform a spherical equivalent correction.

The image plane can be viewed via the viewing optic (e.g., 50 mm FLlens) 1460 and a protective window 1450, with no optical powerpositioned close to the viewing optic 1460. Light sealing features canbe configured to position the eye 1445 and pupil 1446 in any suitablelocation (e.g., 23 mm from the surface of the protective window 1450).In some embodiments, the range of the distance from viewing optic 1460(e.g., the 50 mm FL lens) to the eye 1445 can be 10 mm to 80 mm, 20 mmto 60 mm, or 30 mm to 40 mm.

Further, as noted above, the pupil position 1446 can besubject-dependent and determined using a pupil imaging camera 1476. Asalso noted previously, the optics 1400 can also comprise one or moremirrors 1451 (e.g., at least one dichroic mirror) that is configured toreflect the light from the test bleach and stimulus light sources 1410,1420 onto the subject's pupil.

FIG. 15 is a high-level block diagram of an interface system accordingto embodiments disclosed herein. As noted with reference to FIG. 3, anophthalmic testing system 1550 according to embodiments disclosed hereincan include a digital circuity and relevant hardware 1501 thatimplements the various functions of the ophthalmic testing system 1550.Further, as detailed above, the digital circuitry 1501 can includevarious components including a processor 1510 that is configured tomonitor the operation of the ophthalmic testing system, send and/orreceive signals regarding the operation of the ophthalmic testingsystem, and/or control the operation of the ophthalmic testing system.

The processor 1510 can be configured to collect or receive informationand data regarding the operation of the ophthalmic testing system 1550and/or the head-wearable device 100 and/or store or forward informationand data to another entity (e.g., another portion of an ophthalmictesting system, etc.). The processor 1510 can further be configured tocontrol, monitor, and/or carry out various functions needed foranalysis, interpretation, tracking, and reporting of information anddata collected by the ophthalmic testing system 1550 (for example, asimplemented in the head-wearable device 100 shown in FIG. 1A).Generally, these functions can be carried out and implemented by anysuitable computer system and/or in digital circuitry or computerhardware, and the processor 1510 can implement and/or control thevarious functions and methods described herein. The processor 1510 canfurther be generally configured to monitor the operation of theophthalmic testing system 1550, send and/or receive signals regardingthe operation of the system 1550, and/or control the operation of thesystem 1550. The processor 1510 can also collect or receive dataregarding the operation of the system 1550 and/or store or forward thedata to another entity (e.g., a medical facility, etc.).

Generally, the processor 1510 and the CPU 1515 can be configured toreceive instructions and data from the main memory 1520 (e.g., aread-only memory or a random access memory or both) and execute theinstructions. The instructions and other data can be stored in the mainmemory 1520. The processor 1510 and the main memory 1520 can be includedin or supplemented by special purpose logic circuitry. The main memory1520 can be any suitable form of volatile memory, non-volatile memory,semi-volatile memory, or virtual memory included in machine-readablestorage devices suitable for embodying data and computer programinstructions. For example, the main memory 1520 can comprise magneticdisks (e.g., internal or removable disks), magneto-optical disks, one ormore of a semiconductor memory device (e.g., EPROM or EEPROM), flashmemory, CD-ROM, and/or DVD-ROM disks.

The main memory 1520 can hold application software 1527. For example,the main memory 1520 and application software 1527 can include variouscomputer executable instructions, application software, and datastructures, such as computer executable instructions and data structuresthat implement various aspects of the embodiments described herein. Forexample, the main memory 1520 and application software 1527 can includecomputer executable instructions, application software, and datastructures, such as computer executable instructions and data structuresthat implement a subject-instruction system (e.g., an automatedsubject-instruction system, as detailed below), which can be employed tocommunicate with the subject in order to, for example, instruct thesubject during an ophthalmic test.

The processor 1510 can further be coupled to a database or data storage1530. The data storage 1530 can be configured to store information anddata relating to various functions and operations of the ophthalmictesting and measurement system 1550.

The processor 1510 can further be coupled to a display 1517. The display1570 can be configured to receive information and instructions from theprocessor. The display 1570 can generally be any suitable displayavailable in the art, for example a Liquid Crystal Display (LCD) or alight emitting diode (LED) display. For example, the display 1570 can bea smart and/or touch sensitive display that can receive instructionsfrom a user and/or provide information to the user.

The processor 1510 can further be connected to various interfaces. Theconnection to the various interfaces can be established via a system oran input/output (I/O) interface 1549 (e.g., Bluetooth, USB connector,audio interface, FireWire, interface for connecting peripheral devices,etc.). The I/O interface 1549 can connect to any suitable interface, forexample a microphone 1566, a speaker 1567, and one or more sensors 1541.

The processor 1510 can further be coupled to a communication interface1540, such as a network interface. The communication interface 1540 canbe a communication interface that is included in the ophthalmic testingand measurement system 1550 and/or a remote communications interface1540 that is configured to communicate with the ophthalmic testing andmeasurement system 1550. For example, the communications interface 1540can be a communications interface that is configured to provide theophthalmic testing and measurement system 1550 with a connection to asuitable communications network, through which transmission andreception of data, information, and instructions can occur. As notedabove, the system 1550 can further comprise an optical system 1502 thatcomprises optical components for conducting various ophthalmic tests andmeasurements with the embodiments disclosed herein

The one or more sensors 1541 can comprise any suitable sensors, forexample one or more motion sensors configured to track and/or monitorthe motion and/or movement of the system 1550 and/or the subject. Forexample, the system 1550 can comprise at least one motion sensor 1541(e.g., comprising at least one of an accelerometer and/or a tilt sensor)that is configured to monitor, track, and/or collect informationindicating sudden acceleration or deceleration of the system 1550.

In some embodiments, the system 1550 can comprise a motion sensor and/oran inertial measurement sensor (IMS) that can be used to collectinformation regarding unexpected changes in the motion of the deviceand/or undesired events, such as whether the system 1550 has beendropped (e.g., if a head-wearable implementation of the system has beendropped), whether the system 1550 has taken any undesired impact,whether the system 1550 has been transported from its intended usagefacility (practitioners transporting a tabletop implementation betweenvarious facilities and possibly damaging the device in the process),etc.

The processor 1510 can monitor the sensors and can be configured toreceive and process the information collected by the sensors 1541 can beforwarded. As noted, the information regarding movements of theophthalmic testing system 1550 can include information regarding suddenacceleration or deceleration of the ophthalmic testing system 1550.

The processor 1510 can process this information to determine whether thedevice has suffered an impact (such as a fall or a drop) or experiencedany other event, information about which can be of interest to anauthorized party 1599. Upon processing the information collected by thesensors 1641, the processor 1510 can transmit information regardingundesired events and/or information regarding the status of the system1550 to an entity that tracks, records, and/or makes use of suchinformation. For example, the information regarding unexpected motionsof the device can be transmitted via a communications network 1544 to anentity 1566 (e.g., original manufacturer) that provides/offerswarranties on the system 1550.

The authorized party 1599 can be any entity authorized to receiveinformation about the ophthalmic testing system 1550, such as aninsurance provider (e.g., a party that has insured the ophthalmictesting system), a party that has warrantied any part of the systemand/or any of the services offered by the device, and/or any person orentity that owns or operates the system.

For example, in some embodiments, the authorized party 1599 can be anoriginal device manufacturer that warranties at least a portion of theparts and/or services included in/provided by the ophthalmic testingsystem 1550. Additionally or alternatively, the authorized party 1599can be at least one of a remote entity responsible for maintenance ofthe ophthalmic testing system 1550 and an insurance provider providinginsurance on the ophthalmic testing system 1550.

The processor can be configured to execute instructions to perform oneor more tasks in response to receiving information from the sensor(s)1541. Generally, the processor can comprise pre-established rulescorresponding to different magnitudes of sensor readings and these rulescan govern the nature of a notification to the user or entity 1599.

For example, the processor 1510 can be configured to executeinstructions configured to quantify severity of any undesired event(e.g., sudden acceleration or deceleration events) detected by thesensor(s) 1541. In some embodiments, the processor 1510 can beconfigured to quantify the severity of the undesired event. For example,the processor 1510 can comprise instructions that classify or quantifysudden acceleration or deceleration events as mild, medium, and severe.For example, the processor can be configured to compare the datareceived from the one or more sensors and couple that data withpredetermined thresholds to classify a sudden acceleration ordeceleration event as mild, medium, and severe.

The processor 1510 can further be configured to generate a notification1551 in response to receiving information (from the sensor(s) 1541)which can be of interest to the authorized party 1599 and/or transmitthe generated notification to the authorized party 1599. Thenotification 1551 can be transmitted to the authorized party using anyscheme known and available in the art. For example, the system 1550 canbe configured to transmit the notification 1551 via the communicationsnetwork 1544. The communications network 1544 can be any communicationsnetwork known and available in the art. Further, the system 1550 and theprocessor 1510 can use any means (e.g., communications links,communications protocols, etc.) known and available in the art tocommunicate with the authorized party 1599. The system 1550 can includeany communications means necessary to communicate with the authorizedparty via the communications network 1544.

In some embodiment, the authorized party 1599 can be a designated deviceconfigured to receive the notification 1551 generated by the ophthalmictesting system 1550. The designated device can be any suitable deviceknown and available in the art. For example, the designated device canbe any of a mobile device, a desktop computer, earbud, smart glasseswith pop-up message window.

The third party/designated device 1566 can be configured to issue aresponse signal 1552 to the ophthalmic testing system 1550 in responseto receiving the notification generated by the ophthalmic testing system1550. The response signal 1552 can comprise instructions that can beexecuted by the processor 1510 to perform one or more tasks. Forexample, the one or more instructions can comprise instructions that,once executed by the processor, perform at least one or more ofdisabling the ophthalmic testing device 1550, providing a visual warningsignal to the test subject 1598 (e.g., through the display 1517), andproviding an audible warning signal to the test subject 1598 (e.g.,through the speaker 1567).

Additionally or alternatively, the ophthalmic testing system 1650 can beconfigured to generate an alarm signal in response to detection ofundesired events in the ophthalmic testing system 600 (e.g., suddenacceleration or deceleration of the ophthalmic testing system). In someembodiments, the alarm signal generated by the ophthalmic testing system1550 can be output through at least one speaker 1567. As noted, theprocessor 1510 can be coupled to the at least one speaker 1550 via aninput/output (I/O) interface 1549 of the ophthalmic testing system 1550and configured to instruct the speaker 1550 to generate an alarm signalif/when an undesired event (e.g., sudden acceleration or deceleration ofthe ophthalmic testing system) is detected. In some embodiments, thealarm signal can comprise a message in natural language.

Further, in some embodiments, the one or more sensors 1541 can beconfigured to sense and/or track movements of the test subject 1598. Forexample, the system 1550, in various head-wearable implementations, cancomprise one or more sensors 1541 (e.g., motion sensors, GPS sensors,accelerometers, gyroscopes, etc.) configured to detect or determinewhether the test subject 1598 wearing the system 1550 has moved fromhis/her original position (e.g., from the position at which the system1550 was placed on or against the subject's head). The sensor(s) 1541can be configured to detect any type or amount of movement that may beof interest to the person or entity administering the ophthalmic test.

Further, the processor 1510 can be configured to perform similarprocedures as those performed in response to detection of movement ofthe ophthalmic testing system 1550. Specifically, the processor 1510 canbe configured to generate an alarm signal, send or receive signals,and/or receive and execute instructions in response to detection of anytype or amount of movement that may be of interest to the person orentity administering the ophthalmic test. By way of example, in oneembodiment, the processor 1510 can be configured to issue a signal thatalerts a practitioner that a movement that may be interest to thepractitioner has occurred. In some embodiments, the processor 1510 cancause the display 1517 of the system 1550 to provide a visual message onthe display 1517 of the system 1550.

As noted above, the ophthalmic testing system 1550 can include asubject-instruction system 1560 that is configured to issue variousinstructions for carrying out the test to the subject. Thesubject-instruction system 1560 can be implemented in the electroniccircuitry of the ophthalmic testing system 1550, for example inapplication software 1527, and configured such that one or moreinstructions for guiding a subject can be stored in the form ofinstructions and/or audio files (e.g., in the form of Waveform AudioFile Format) in the main memory 1520. The subject-instruction system canbe configured such that upon initialization of the testing system 1550,the processor 1510 transfers audio files for instructing the subjectusing the subject-instruction system 1560 from the main memory andcauses the execution of the files. The subject-instruction system 1560can communicate, via the I/O interface 1549, with the one or morespeakers 1567 of ophthalmic testing and measurement system 1550, andinstruct the speakers 1567 to play the relevant audio files for thesubject.

In some embodiments, the subject-instruction system 1560 can be employedto guide a subject, automatically, through an ophthalmic test ormeasurement. For example, the subject-instruction system 1560 can guidea subject through the required steps for performing an ophthalmic test,such as a dark adaptation test.

The subject-instruction system 1560 can be configured to be initializedin response to any suitable trigger known in the art. For example, thesubject-instruction system 1560 can be configured such that it isinitialized in response to the system 1550 being turned on, in responseto activation of a button (e.g., on the display 1517), in response tothe frame of the device coming in contact with the subject's skin (touchsensitive), and/or in response to the head-wearable headset being wornby the subject. Once initiated, the subject-instructions system 1560 canprovide the subject with an explanation of how the test is performedand/or guide the subject through the procedures required for completionof the ophthalmic test and/or study. In one embodiment, thesubject-instructions system 1560 can be mounted on the headset of ahead-wearable implementation and configured to instruct the subjectduring the ophthalmic test and/or study (e.g., during performance of adark adaptation measurement).

The subject-instruction system 1560 can further be configured to guidethe test subject 1598 through an ophthalmic test by establishing, usingthe processor 1510, verbal communication with the test subject 1598. Theverbal communication with the subject can be conducted using naturallanguage. Additionally or alternatively, the verbal communication withthe test subject 1598 can be performed by using one or more pre-recordedmessages configured for delivery to the test subject 1598 before,during, and after the ophthalmic test. The pre-recorded messages can bestored in the database 1530 and accessed by the processor 1510 atvarious point during the ophthalmic test. The processor 1510 can use theaudio speaker 1567 to conduct verbal communication with the test subject1598.

The verbal communication can comprise one or more commands conveyed tothe test subject 1598. For example, the verbal communication can includecommands that guide the subject through the test by instructing thesubject to focus on a certain fixation point, instructing the subject tokeep his/her eyes open, instructing the subject to blink/not to blink atcertain points of time during the test, etc. Additionally oralternatively, the one or more commands can include communicationsexchange (e.g., by providing verbal commands to the subject andreceiving natural language responses from the subject) between thesystem 1550 and the subject. In order to achieve the communicationexchange, the system 1650 can utilize an audio inlet (e.g., speaker1566) to receive communication messages from the test subject 1598. Thecommunication messages can be issued by the test subject 1598 in naturallanguage.

For example, the one or more commands can comprise communicationsexchange requesting information regarding subject's records (e.g.,subject's address, phone number, insurance, prescriptions, preferredpharmacy, etc.), advertisements for recommended treatments or tests,education regarding lifestyle changes associated with a condition orslowing disease progression, etc. In some embodiments, the one or morecommands can provide the subject with information such as referral toanother provider or physician (e.g., ophthalmologist, retina specialist,etc.).

Further, the one or more commands can comprise commands provided forguiding the test subject 1598 through the ophthalmic test. For example,the verbal communication can comprise at least one of 1) greeting thetest subject 1598, 2) commands providing address or location of an examroom in which the ophthalmic test is administered, 3) informationregarding the ophthalmic test, and 4) expected wait time until theophthalmic test is administered.

The processor 1510 can be configured to monitor the response receivedfrom the test subject 1598 via the interface 1555. In some embodiments,the processor 1510 can be configured to store the response received fromthe test subject 1598 for future analysis and compare the responsereceived from the test subject 1598 to a baseline response stored in thememory. The processor 1510 can further be configured to adjust at leastone function of the ophthalmic testing system based on the responsereceived from the test subject 1598. For example, the processor 1510 canbe configured to monitor a test subject's response to a stimulus lightand, based on the subject's response, determine whether the length ofthe test should be shortened or extended. Alternatively or additionally,the processor can be configured to change various configurations of theophthalmic testing system 1550 based on the response received from thetest subject 1598. For example, the processor can change at least one ofposition of a component of the optical system and orientation of acomponent of the optical system. Additionally or alternatively, theprocessor can adjust at least one of 1) position of a component of theoptical system, 2) orientation of a component of the optical system, and3) length of the ophthalmic test. In some embodiments, the processor canalso provide the test subject 1598 with additional instructions uponreceiving a response from the test subject 1598.

As noted, the system 1550 can comprise an audio inlet, such as amicrophone 1566 that is configured to receive a verbal response from thetest subject 1598. The verbal response of the test subject 1598 can beprovided to the system 1550 in the form of natural language and beprocessed by the processor 1510. The processor 1510 can process theverbal response of the test subject 1598 and provide the test subject1598 with additional commands and instructions. The additional commandscan comprise at least one of 1) natural language commands, 2)pre-recorded audio commands, 3) computer-generated audio commands, 4)visual commands, and 5) physical commands or prompts (e.g., vibrations).

The system 1550 can process the instructions received from the subjectby extracting one or more active elements of an active ontologyassociated with the user's response, determining at least one task forwhich to provide the test subject with assistance based on the activeontology, and providing the test subject with assistance by performingthe at least one task. Generally, any suitable technique available inthe art can be used to extract the active ontology associated with theuser's verbal response.

In some embodiments, the verbal response of the test subject 1598 cancomprise one or more requests for assistance. The one or more requestscan be issued by the test subject 1598 in natural language. In responseto receiving the verbal request for assistance, the processor 1510 canextract one or more active elements of an active ontology associatedwith the one or more requests, determine at least one task for which toprovide the test subject 1598 with assistance based on the activeontology, and provide the test subject 1598 with assistance byperforming the at least one test. Non-limiting examples of assistivetasks can include provision for a rest break or pause in the test,clarification of how to don or remove the given ophthalmic test system,clarification or repeating of test instructions, and additionalinformation or education about the test procedure, instrumentation,anatomy, and/or physiology related to the test.

As noted, the subject-instructions system 1560 can be configured toguide a test subject 1598 through the test and the test environment. Forexample, upon arriving at the testing location 1547, the test subject1598 can be paired with a device 1537 configured to track and/or reportthe exact location of the test subject. The device 1537 can be a mobiledevice associated with the subject 1598. The device 1537 can beconfigured such that it communicates the location of the test subject1598 within the test environment 1547 to the processor 1510. In otherwords, the processor 1510 can be configured to communicate (via acommunication link or network 1544) with the location-determining device1537 associated with the test subject 1598 to monitor the location ofthe test subject and guide the test subject 1598 through the testinglocation 1547 to the exam room 1557. It should be noted that althoughshown as the processor 1510 of the ophthalmic testing system 600, theprocessor can be any processor in the testing location 1547, for examplea processor implemented in or coupled with the location-determiningdevice 1537. Further, embodiments disclosed herein are not limited touse with ophthalmic testing systems. Generally, the systems, methods,and apparatus disclosed herein for guiding test subjects through atesting location to an exam room can be used in any testing or examfacility (having medical or non-medical nature) or any facility in whicha client is instructed to wait and/or needs to be directed to a locationwhere he/she receives his/her intended services. Further, any portion ofthe systems disclosed herein can be implemented on a chip. For example,the systems for determining the health of the system can be implementedon a chip and installed in any device, the health which an authorizedparty may be interested in tracking.

Referring back to FIG. 15, the processor 1510 can further be configuredto communicate with a plurality of speakers 1557 dispersed throughoutthe testing location 1547 for guiding the test subject to the exam room1557. The processor 1510 can activate each of the speakers based 1557 onproximity of the location of the test subject location-determiningdevice 1537 to that speaker 657. Alternatively or additionally, theprocessor 1510 can be configured to communicate with a program executingon the subject location-determining device 1537 for presenting a map tothe test subject and visually guiding the test subject to the exam room1557. In some embodiments, the location-determining device 1537 cancomprise an RFID tag interfacing with RFID readers distributedthroughout a clinic or office. Further, in some implementations, thelocation-determining device can comprise a smartphone interfacing withan office or clinic-based WiFi or Bluetooth network.

The processor 1510 can issue one or more commands comprisingpre-recorded messages to the test subject 1598. The one or more commandscan be configured for delivery to the test subject before, during, andafter the ophthalmic test. The processor 1510 can also receive one ormore requests for assistance from the test subject 1598. The one or morerequests can comprise at least one of 1) questions regarding the testand 2) complaints regarding the test.

Further, the processor can be configured to execute instructions thatprovide the test subject with assistance by performing at least oneof: 1) guiding the test subject 1598 in conducting the ophthalmictesting, 2) notifying a practitioner monitoring the ophthalmic testing,3) adjusting at least one function of the ophthalmic measurement andtesting device, and 4) configuring at least one element of theophthalmic measurement and testing device.

FIG. 16 is a high-level flow diagram of the procedures that can be usedby the subject-instruction system 1560 to provide the subject withinstructions for performing and/or completing of the ophthalmic testand/or study. As shown in FIG. 16, the procedures can comprise devicepreparation 1610, subject preparations 1620, alignment 1630,demonstration 1640, ophthalmic test 1650, and test completion 1660.

During device preparation 1610, the test subject is prepared for theophthalmic test and test parameters are set. The test subject can beprepared by a technician, physician, or a practitioner and/or by anautomated system that automatically sets the parameters for conductingtest. Specifically, during subject preparations 720, the test subjectcan be provided with an introduction to the ophthalmic testing system(e.g., the head-wearable implementation of the system) and provided withguidance as how the system operates and/or the procedures that thesubject must follow in order to complete the ophthalmic test. Thesubject can receive the introductory comments from a live technician,physician, or a practitioner and/or from an automated system that isconfigured to guide the test subject through the test. For example, thesubject can be introduced to the ophthalmic testing system by beingguided to watch a video and/or by being guided through a simulated or asample test. In embodiments that utilize an automated system, thesubject can be given the option of communicating with the automatedsystem via audio commands. The audio commands can be provided by thesubject in natural language. As described with reference to FIG. 4A,During the test subject preparation phase, the clinician can use theinterface 460 to setup the test and initialize the test. Once the testis setup, the clinician can pass the interface 460 to the test subjectfor use in conducting the test.

During the alignment 1630 phase, the ophthalmic testing system canautomatically align the subject's pupils to the image plane (e.g.,crosshairs included in the image plane). The subject's pupils can bealigned to the image plane manually (e.g., by a technician) and/or usingan automated system that automatically detects the subject's pupils andadjusts the image plane accordingly. As shown in FIG. 15, in someembodiments, the ophthalmic testing system 1550 can comprise a providerinterface 1511 that has been configured to allow an operator (e.g.,technician) to align the subject's pupils to crosshairs or otherfeatures included in the image plane. For example, the providerinterface can comprise a display 1511 d that displays an image of thesubject's pupil and also an image of the image plane and allows theclinician to adjust the pupil to the image plane (e.g., cross hairs onthe image plane). Adjustments on the screen 1511 d of the providerinterface 1511 can trigger the processor 1510 to move the platformscarrying the optical elements (e.g., light sources, as described withreference to FIG. 6) of the optical system 1502, thereby bringing thesubject's pupils in alignment with the image plane.

During demonstration 1640, the ophthalmic testing system canautomatically take the subject through a demonstration test to informthe subject of the testing procedures. During the ophthalmic test 1650,the ophthalmic testing system can automatically take the subject throughthe actual ophthalmic test to collect data and/or images. The test iscompleted 1660 by the technician/subject removing the subject from thedevice and/or collecting the head-mounted device from the subject andlogging the results into the subject's record. As described withreference to FIG. 4A, at this point of the testing process, theprocessor 1510 can bring the interface 460 back into the clinician mode.

Referring back to FIG. 15, the system 1550 can further comprise aprovider interface 1511 and/or a command screen 1550 that can allow aprovider to select from among multiple head-wearable devices, eachoffering a different ophthalmic test. Specifically, as noted withreference to FIGS. 4A and 4A-1, the ophthalmic testing system 1550 canbe configured to provide the clinician with one or more menus or iconsfor use in initializing and/or conducting an ophthalmic test. The menusand icons can be presented to the provider and/or the test subject viathe provider interface 1511 and/or via a command center 1566 that isconfigured to control functions of the system 1550. The providerinterface 1511 and/or the command center 1566 can be configured to storeor access a database 1530 that stores information regarding the devicesthat offer various tests and the test(s) offered (e.g., cloud-basedsubject database), electronic health record, or practice managementsystem.

The display 1511 d/1566 d of the interface 1511/command center 1566 canpresent to a user a plurality of icons a,b,c/a′,b′,c′, each of which canrepresent one of the systems 1550, 1550′, 1550″ (e.g., one of multiplehead-wearable devices) that is in communication with the command center1566/interface 1511. In some embodiments, the user can select an icon,e.g., by clicking on that icon, to initiate communication with thehead-wearable device associated with that icon. By way of example, byselecting an icon a,b,c/a′,b′,c′, the user can establish a communicationchannel with a head-wearable device corresponding to that icon. Theselection of an icon a/a′ can result in selection of the device 1550corresponding to that icon. Once the device 1550 is selected, the systemcan present a menu 1050 to the user, which contains a list of commandsfrom which the user can choose for instructing the head-wearable device1550 associated with that icon al a′ to perform a desired function. Forexample, the menu a can include a menu item d that allows the providerto determine whether device is being worn or used by another user. Byselecting menu item d, the provider can determine whether a particularhead-wearable device 1550 is being worn by a subject.

In response, the command center can receive data from one or moresensors 1571 incorporated on the head-wearable device to determinewhether the head-wearable device is being worn by a subject (e.g., forexample a pressure sensor included in the strap of a head-wearableimplementation, where the pressure sensor is in communication with theprocessor 1510 and the processor 1510 can determine based on theinformation received from the sensor if the head-wearable device isbeing worn).

Subsequently, another menu item e, can be presented on the screen 1566d/1511 d. The selection of this menu item can provide the user with theoption of communicating with the subject, thereby allowing the providerto initiate verbal and/or visual communication with a subject wearingthe head-wearable device 1550. For example, upon selection of this item,the command center 1566 can allow the user to provide verbalinstructions to the subject, e.g., to prepare the subject for theinitiation of an ophthalmic test. The user can then select another menuitem fto initiate a test using the ophthalmic testing system 1550 on thetest subject 1598.

Those having ordinary skill in the art will appreciate that variouschanges can be made to the above embodiments without departing from thescope of the invention. Although this specification discloses advantagesin the context of certain illustrative, non-limiting embodiments,various changes, substitutions, permutations, and alterations may bemade without departing from the scope of the specification as defined bythe appended claims. Further, any feature described in connection withany one embodiment may also be applicable to any other embodiment.

1. A head-wearable device for measurement of dark adaptation in at leastone eye of a subject, the head-wearable device comprising: ahead-wearable frame; at least one test light source mounted in the frameand configured to generate a bleaching light and a stimulus light; andan optical system mounted in the frame and configured to direct thebleaching light and the stimulus light from the at least one test lightsource onto at least one eye of the subject.
 2. The head-wearable deviceof claim 1, further comprising a movable platform on which the at leastone test light source and the optical system are mounted, the movableplatform being movable along at least two orthogonal directions andconfigured to align the at least one test light source relative to thepupil of the subject's eye.
 3. (canceled)
 4. (canceled)
 5. Thehead-wearable device of claim 1, further comprising at least onefixation light source configured to direct the subject's attention tothe at least one test light source, the fixation light source and the atleast one test light source being positioned relative to one anothersuch that a light beam emitted by the at least one test light source anda fixation light beam emitted by the fixation light source form an anglein a range of about 1 to about 18 degrees at the subject's pupil. 6.(canceled)
 5. The head-wearable device of claim 5, wherein the at leastone fixation light source is configured to be movable, along a directionsubstantially along a propagation direction of light emitted by thefixation light source, to allow bringing the fixation light beam intofocus when viewed by the subject.
 8. (canceled)
 9. The head-wearabledevice of claim 1 further comprising a mechanism mounted onto thehead-wearable frame and coupled to the at least one fixation lightsource, the mechanism being configured to move the fixation light sourcerelative to the subject's eye. 10-23. (canceled)
 24. The head-wearabledevice of claim 1 further comprising a light seal configured to isolateeyes of the subject from ambient light independent of one another. 25.The head-wearable device of claim 24, wherein the light seal issubstantially conformable to at least a portion of the subject's head.26. (canceled)
 27. (canceled)
 28. The head-wearable device of claim 1further comprising a strap coupled to the frame and configured to adjustattachment of the frame to the subject's head.
 29. The head-wearabledevice of claim 28, further comprising a quick release button coupled tothe strap and configured to allow facile release thereof.
 30. Thehead-wearable device of claim 24, wherein the light seal comprises apolymeric material. 31-36. (canceled)
 37. The head-wearable device ofclaim 24, wherein the light seal comprises a conformable body having atleast one opening adapted to be substantially aligned with the at leastone eye of the subject when the light seal is worn by the subject, theconformable body being further configured to be coupled to the frame ofthe head-wearable device such that the combination of the head-wearabledevice and the light seal isolate the at least one eye of the subjectfrom ambient light when worn by the subject. 38-40. (canceled)
 41. Thehead-wearable device of claim 24, further comprising a hygienic linerconfigured for coupling with a surface of the conformable body of thelight seal, the hygienic linger being configured to be in contact withthe subject's skin when the light seal is worn by the subject.
 42. Thehead-wearable device of claim 41, wherein the hygienic liner is asingle-use, disposable item.
 43. The head-wearable device of claim 42,wherein the hygienic liner comprises an RFID tag.
 44. The head-wearabledevice of claim 24, further comprising one or more light sensors coupledto the frame for detecting light leakage through the light seal.
 45. Thehead-wearable device of claim 44, wherein the one or more light sensorsare positioned in vicinity of at least one eye of the subject andconfigured to detect light leakage in the vicinity of the at least oneeye.
 46. (canceled)
 47. The head-wearable device of claim 44, furthercomprising an alert module mounted onto the frame and in communicationwith the one or more light sensors, the alert module being configured togenerate an alert when the detected light leakage is greater than athreshold.
 48. (canceled)
 49. (canceled)
 50. The head-wearable device ofclaim 47, wherein the alert module is configured to inform an individualadministering the dark adaptation test of completion of the test. 51.The head-wearable device of claim 47, wherein the alert module isconfigured to generate an alarm signal in response to malfunction of theat least one test light source.
 52. The head-wearable device of claim47, wherein the alert module is configured to generate an alarm signalin response to performance of the subject during the dark adaptationmeasurement. 53-70. (canceled)
 71. The head-wearable device of claim 1,wherein the head-wearable frame is configured such that at least aportion thereof is positioned in front of the at least one eye when thehead-wearable device is worn by a subject. 72-81. (canceled)
 82. Thehead-wearable device of claim 1, further comprising a subject-responseinterface configured to allow the subject to provide feedback inresponse to exposure to light emitted by the at least one test light.83. The head-wearable device of claim 82, further comprising an analyzermounted on the frame and in communication with the subject-responseinterface and configured to analyze the feedback.
 84. The head-wearabledevice of claim 83, wherein the analyzer is configured to analyze thefeedback of the subject for assessing dark adaptation of the at leastone eye of the subject. 85-93. (canceled)
 94. The head-wearable deviceof claim 1, further comprising a controller coupled to the frame forcontrolling the at least one test light source.
 95. The head-wearabledevice of claim 94, further comprising a display coupled to the frame,the display being controlled by the controller.
 96. The head-wearabledevice of claim 95, wherein the controller effects presentation of atleast one of: information, selection options, and command options on thedisplay, and wherein the information comprises status of the measurementof dark adaptation.
 97. (canceled)
 98. (canceled)
 99. The head-wearabledevice of claim 96, wherein the selection options allow a user to selectright eye, left eye, or both eyes of the subject for administration ofthe dark adaptation test thereto.
 100. The head-wearable device of claim96, wherein the selection options allow selecting a protocol forperforming the dark adaptation measurement.
 101. (canceled) .
 102. Thehead-wearable device of claim 96, wherein the display presentssoftware-controlled buttons for allowing a user to input data into thehead-wearable device. 103-295. (canceled)